Symptoms and General Pathology

All Conditions

Flushing

Skin Manifestations

Michael McNamara, MD

This study is to compare the rate of adverse events in subjects with maintenance flushes greater than 28 days.

This study is a retrospective, multi-center data collection study to support extending the maximum recommended maintenance flushing intervals in subjects who have Bard totally implanted ports with distally-valved catheters.

This study is intended to provide clinical evidence in support of extending the maximum recommended maintenance flushing interval to a time point of potentially \>28 days for Bard ports with distally-valved catheters.

Reduction in the number of maintenance flushes could help alleviate the inconvenience, reduce the time and expense, and minimize the invasive nature of the maintenance flushing procedure for patients and medical institutions. Subjects will be eligible for analysis of the primary endpoint after the first successful maintenance flush of the port until (a) the first adverse event or (b) abandonment of the port.

A financial analysis will be performed on an institutional basis to determine the approximate mean cost of flushing. These costs will be extrapolated into an approximate per-patient cost for the different flushing period durations. No financial information will be collected from subject medical records. All required information will be extrapolated from site staff.

Study to Extend the Maximum Maintenance Flushing Interval for Ports With Distally Valved Catheters

A Retrospective Study to Extend the Maximum Maintenance Flushing Interval for Ports With Distally Valved Catheters

Study was terminated due to limited number of adverse events recorded.

Subjects' maintenance flush intervals were collected by calculating the number of days since a previous flush. A total of 1,035 maintenance flush intervals were recorded at all sites. The numbers of flushing intervals available for analysis are 1,035 representing 49,696 patient days were recorded in 171 subjects.

C. R. Bard

Adverse events were assessed separately for each flushing interval, and not for each participant

Group A

Group B

Group C

Demographics of 171 subjects that contributed to final data analysis

Combined Demographics

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Ethnicity (NIH/OMB)

United States

Region of Enrollment

Solid tumor

Hematologic

Cancer Type

Jugular

Subclavian

Unknown

Port Access Vein

Single Lumen

Dual Lumen

Port Configuration

7Fr.

8Fr.

9.5Fr.

#Fr. (French units) refers to the functional lumen/relative size of the catheter's diameter with smaller numbers indicating smaller diameters. Each increment of French sizing equals 0.33 mm.

Catheter Configuration

Post-infusional chemotherapy subjects that had Bard implanted ports with distally valved catheters.

Christopher DiMatteo

The Rate of Adverse Events in Group A (1-28 Day Flushing Interval) Versus Extended Accession Intervals in Group B (29-56 Day Flushing Interval), and Group C (57+ Days).

Overall Study

Heart and Blood Diseases

Syndrome

Recurrence

Thrombosis

Venous Thrombosis

Postthrombotic Syndrome

Postphlebitic Syndrome

Disease Attributes

Embolism

Embolism and Thrombosis

Vascular Diseases

Venous Insufficiency

Phlebitis

Peripheral Arterial Disease

Peripheral Vascular Diseases

Fibrinolytic Agents

Anticoagulants

All Drugs and Chemicals

Anti-Infective Agents

Amino Acids

Heparin

Enoxaparin

Edoxaban

Rivaroxaban

Apixaban

Dabigatran

Calcium heparin

Heparin, Low-Molecular-Weight

Tinzaparin

Dalteparin

Enoxaparin sodium

Factor Xa Inhibitors

Antithrombins

Antithrombin III

Protease Inhibitors

Serine Proteinase Inhibitors

HIV Protease Inhibitors

Enzyme Inhibitors

Serine

Enoxaparin 1 mg/kg subcutaneously every 12 hours for one month following catheter removal or alternate enoxaparin dose or interval based on anti-factor Xa testing that was obtained by clinical team.

Apixaban, rivaroxaban, dabigatran, or edoxaban at standard dosing per FDA package insert for direct oral anticoagulants.

Cancer patients will be treated with enoxaparin 1 mg/kg subcutaneously every 12 hours for one month following catheter removal or alternate enoxaparin dose or interval based on anti-factor Xa testing obtained by the clinical team or either apixaban, rivaroxaban, dabigatran, edoxaban following a catheter related blood clot

Heparin, Low-Molecular-Weight, or direct oral anticoagulants

Lisa M Baumann Kreuziger, MD, MS

The goal of the pilot study is to determine if a multicenter prospective cohort study of cancer patients with blood clots associated with catheters is feasible. Cancer patients with catheter-related thrombosis treated with one month of anticoagulation will be evaluated for for post-thrombotic syndrome. Laboratory biomarkers will be evaluated as predictors of recurrent thrombosis.

Participants may be referred for screening at Medical College of Wisconsin (MCW) in two possible mechanisms: participant contact study staff from information on Clinical Trials Science Institute (CTSI) FACT website or referral from treating Hematologist or Oncologist. At MCW, an EPIC report will be generated to identify people with catheter related thrombosis (CRT). The treating provider would then be contacted to determine if referral to the study was appropriate. Subjects at Ohio State University (OSU) will be referred from the treating Hematologist or Oncologist. A report generated in Epic will be used to identify people with CRT. The treating provider would then be contacted to determine if referral to the study was appropriate. Participants will be given printed information about the study or verbal explanation using the informational flyer. Verbal consent will be obtained to be screened for participation and contacted by study personnel. Screening will be completed by BloodCenter of Wisconsin (BCW) nurse coordinator. We aim to consent and enroll patients after diagnosis of catheter-related thrombosis and prior to catheter removal. Consent and enrollment (Visit 1) must occur prior to discontinuation of anticoagulation. Participants will be treated with either enoxaparin for one month following catheter removal, or direct oral anticoagulant treatment (apixaban, rivaroxaban, dabigatran, or edoxaban). Anticoagulation will be continued for 1 month after catheter removal. The minimum duration of anticoagulation will be one month and maximum duration is 7 months. The cost of enoxaparin will be the responsibility of the participant as use of the medication is part of routine care. Subjects will be contacted by telephone prior to discontinuation of anticoagulation to review study protocol, assess for bleeding, and see if any continuation rules apply and arrange for research visit 2 in the following 1-2 weeks. Visits 3 and 4 will occur 3 and 6 months after catheter removal, respectively. At visits 3 \& 4, Medical history, cancer history, and medications will be updated. At each visit, participants will be assessed for post-thrombotic syndrome using the modified Villalta scale and functional limitation using the DASH questionnaire. At MCW, surveys will be administered by the research coordinator and/or Translational Research Unit (TRU) staff and physical examination will be completed by BCW nurse coordinator. At OSU, surveys will be administered by research coordinators and physical examination will be administered by research nurse coordinator. Laboratory samples will be obtained for MCW participants only.

Post-thrombotic Syndrome & Predictors of Recurrence in Catheter-related Thrombosis

Pilot Study of Post-thrombotic Syndrome & Predictors of Recurrence in Cancer Patients With Catheter-related Thrombosis

The number of participants with post-thrombotic syndrome 6 months after catheter removal in cancer patients with catheter-related thrombosis treated with 1 month of anticoagulation

Number of participants with recurrent thrombosis in cancer patients with catheter-related thrombosis treated with 1 month of anticoagulation

Number of participants with major bleeding in cancer patients with catheter-related thrombosis treated with 1 month of anticoagulation

Percentage of participants who completed post-thrombotic syndrome assessments

Number of participants that completed sample collection for biomarker analysis to predict recurrent venous thrombosis

Versiti

Ohio State University

Medical College of Wisconsin

Assistant Professor

Enoxaparin 1 mg/kg subcutaneously every 12 hours for one month following catheter removal or alternate enoxaparin dose or interval based on anti-factor Xa testing that was obtained by clinical team.

Apixaban, rivaroxaban, dabigatran, or edoxaban at standard dosing per FDA package insert for direct oral anticoagulants.

Heparin, Low-Molecular-Weight, or direct oral anticoagulants: Cancer patients will be treated with enoxaparin 1 mg/kg subcutaneously every 12 hours for one month following catheter removal or alternate enoxaparin dose or interval based on anti-factor Xa testing obtained by the clinical team or either apixaban, rivaroxaban, dabigatran, edoxaban following a catheter related blood clot

Low-molecular-weight Heparin or Direct Oral Anticoagulant

Dr Lisa Baumann Kreuziger

PTS Assessment Completion

Biomarker Sample Collection

Number of Participants With Post-thrombotic Syndrome

Number of Participants With Recurrent Thrombosis

Number of Participants With Major Bleeding

Neoplasms

Blood and Lymph Conditions

Rare Diseases

Leukemia

Neoplasms by Histologic Type

Hematologic Diseases

Acute Graft Versus Host Disease

Patients receiving normal management with dressings changed once a week according to the SF2H recommendations.

Patients whose dressings are changed every other day.

The patient circuit corresponds to that of usual care.

Not part of usual patient management:

* The rhythm of PICCline dressing changes, which differed between the two groups.
* The collection of pain on a visual analog scale at each dressing change.

Dressing change

Éric JOURDAN, Dr.

Anissa MEGZARI

Séverine LOURS, Mme.

Franciane PAUL, Dr.

Julie LASSALLE, Mme.

Peripherally Inserted Central Catheters have been widely used for many years for the administration of chemotherapy to patients with cancer. However, its use entails significant infectious complications and high risks of death.The hypothesis is that increasing the rate of PICCline dressing changes will reduce the occurrence of catheter-related infections.

The PICCline ("Peripherally Inserted Central Catheter") is a central catheter whose brachial insertion is peripheral. It has been widely used for many years for the administration of chemotherapy to patients with cancer. Although its use is growing (2.7 million applications in the USA in 2020), significant infectious complications (especially bacteremia) and even high risks of death are generally associated with it.

In December 2013, the French Society of Hospital Hygiene (SF2H) published a guide of "Recommendations for good practices and management of risks associated with PICC" to help professionals in the use of this device. It states that the rate of dressing repair is set at a maximum of 8 days for a sterile semipermeable transparent dressing; however, this recommendation is based on a questionable level of evidence (grade E level of evidence according to the HAS). In the appendix to this guide, the analysis of the scientific literature does not highlight any articles comparing different dressing repair rates. An observational study was conducted at the University Hospital of Nîmes, in order to determine the rate of infection on PICCline in the Hematology Department. In 2019, out of the 90 PICClines applied (dressing changes every 2 days), 12 infections (local and/or systemic) were noted, i.e. 13.3%.

In order to know the current practices of the different hematology services in France, a survey was conducted to collect protocols for PICCline dressing changes. A total of 23 haematology departments were contacted, 18 of which responded. The observation was made that, although most departments respected the SF2H recommendation (15 out of 18), others proposed different rhythms of care: (a) in the Hematology department at Nîmes University Hospital, dressings are redone every 48 hours, (b) in Montpellier, the frequency was 2 to 3 times a week, (c) in Grenoble, the use of PICCline was abandoned by the medical team who noted too many infections and thromboses associated with this device, and (d) in Toulouse and Strasbourg, the PICCline was used less and less for these same reasons. Moreover, the SF2H recommendations are addressed in a general way to professionals and valid for all patients; but no study can currently affirm that they are applicable to a fragile population of immunocompromised patients in the context of intensive chemotherapy. Hematology patients have a high risk of febrile neutropenia, of around 80%, and this risk of immunosuppression is a non-negligible point in terms of infection prevention during patient management.

In 2019 in France, the Réseau de Prévention des Infections Associées aux Soins launched a campaign to monitor and prevent infections associated with invasive devices. For 3 months, data on the occurrence of infectious episodes were collected in 1001 healthcare facilities. Of the nearly 12,000 bacteremia episodes identified, 25.4% were associated with an intravascular device, 17% of which were PICCline. Moreover, the survey revealed that the highest rates of occurrence were found in the Intensive Care Unit, Oncology and Hematology departments and the prevalence of bacteremia associated with intravascular devices in Hematology represented 39.8%.

Hypothesis : increasing the rate of PICCline dressing changes will reduce the occurrence of catheter-related infections.

Prospective two-center randomized open-label controlled pilot study in two parallel groups according to PICCline dressing repair: (i) Control group (every 8 days, see SF2H recommendations), (ii) Experimental group (every 2 days).

Study of the Impact of Frequency of Changing PICCline Dressings in Patients With Acute Leukemia

The medical history of each patient in the control group will be recorded.

The medical history of each patient in the experimental group will be recorded.

The type of leukemia of each patient in the control group will be recorded

The type of leukemia of each patient in the experimental group will be recorded

The treatment start date of each patient in the control group will be recorded

The treatment start date of each patient in the experimental group will be recorded

The date when each patient in the control group started aplasia will be recorded

The date when each patient in the experimental group started aplasia will be recorded

The date when each patient in the control group ended their aplasia will be recorded

The date when each patient in the experimental group ended their aplasia will be recorded

The date when each patient in the control group was discharged from hospital will be recorded.

The date when each patient in the experimental group was discharged from hospital will be recorded.

The antibiotic therapy provided to each patient in the control group will be recorded

The antibiotic therapy provided to each patient in the experimental group will be recorded

For each patient in the control group. Recorded as YES/NO

For each patient in the experimental group. Recorded as YES/NO

For each patient in the control group : YES/NO and date

For each patient in the experimental group : YES/NO and date

Device-related data: number and types of previous central lines, history of infection, type of device, number of lines, type of fixation, type of dressing, device use protocols, description of puncture site appearance, related intercurrent events, identified germs will be recorded for each patient in the control group.

Device-related data: number and types of previous central lines, history of infection, type of device, number of lines, type of fixation, type of dressing, device use protocols, description of puncture site appearance, related intercurrent events, identified germs will be recorded for each patient in the experimental group.

Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.

The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.

The patient will be asked to evaluate pain according to a visual analog scale following each dressing change.

The duration of time in hospital will be measured from the first day of receiving chemotherapy until transfer towards a healthcare facility for follow-up and rehabilitation or return home.

If an infection on the PICCline is suspected, the device will be removed and blood cultures will be taken from the PICCLine and the periphery. If the PICCline culture is positive and the blood cultures negative, the infection is local and device-related. If the PICCline culture and peripheral blood cultures are positive, then catheter-related bacteremia is diagnosed. If general signs like fever appear in a patient with a PICCline without local signs of infection, then blood taken from the periphery and blood from the PICCLine will be cultured. If both blood cultures are positive, catheter-related bacteremia is highly probable. If the blood culture bottle taken from the periphery remains negative and there is a strong suspicion of infection related to the PICCline, then new blood cultures from the periphery and from the device will be performed in order to be able to conclude that there is bacteremia/device colonization/contamination.

University Hospital, Montpellier

Centre Hospitalier Universitaire de Nīmes

Infections

Communicable Diseases

Central Nervous System Depressants

Ethanol

Usual care for central line while patients are at home and then switch to usual care plus 70% isopropyl alcohol after washout.

Use of 70% isopropyl alcohol embedded caps on central lines in addition to usual care of central line in the home setting and then switch to usual care only after washout.

70% Isopropyl alcohol embedded caps

This involves the Best Practice Central Line Maintenance Care Bundle which includes;

1. Daily assessment whether central line is needed
2. Central line Site Care
3. Central line Hub/Cap/Tubing Care

Usual Care

Marlene R. Miller, MD, MSc

Aaron Milstone, MD, MHS

The overall goal of this Community Central Line Infection Prevention (CCLIP) trial, supported by grant R01 HS022870 from the Agency for Healthcare Research and Quality, is to determine whether use of a promising new intervention, namely 70% isopropyl alcohol embedded protective caps on central lines, in the home setting is associated with a reduction in ambulatory central line-associated bloodstream infections (CLABSI) in a high-risk population of pediatric hematology/oncology patients. Despite successes in CLABSI reduction efforts for inpatients, it remains unknown what generalizable best practices should be with chronic central lines in the home setting and how effective involving patients and caregivers across multiple institutions in CLABSI reduction efforts will be. This research will involve a cluster-randomized, cross-over design, clinical trial. This proposal will focus on the caregivers integral to ambulatory pediatric central line care: patients and families. The specific aims of the proposed research program are:

Specific Aim #1: Evaluate whether use of 70% isopropyl alcohol embedded protective caps on central lines reduces the rate of CLABSI in ambulatory pediatric hematology/oncology patients.

Hypothesis: Use of 70% isopropyl alcohol embedded protective caps on central lines will be associated with at least a 25% reduction in the ambulatory CLABSI rate for pediatric hematology/oncology patients.

Specific Aim #2: Evaluate whether use of 70% isopropyl alcohol embedded protective caps on central lines reduces the rate of all positive blood cultures in ambulatory pediatric hematology/oncology patients.

Hypothesis: Use of 70% isopropyl alcohol embedded protective caps on central lines will be associated with at least a 25% reduction in the positive blood culture rate at home for pediatric hematology/oncology patients.

Specific Aim #3: Evaluate whether the use of 70% isopropyl alcohol embedded protective caps on central lines changes the distribution of bacteria isolated from blood cultures of pediatric hematology/oncology patients.

Hypothesis: Use of 70% isopropyl alcohol embedded protective caps on central lines will reduce Gram-positive CLABSI, secondary blood steam infections, and single positive blood cultures at home for pediatric hematology/oncology patients.

Study Design and Population: The proposed study will use a cluster-randomized, 2 period crossover design, clinical trial to evaluate a promising new intervention, namely 70% isopropyl alcohol embedded protective caps, to reduce CLABSIs, 2ndry BSI, and SPBC at home for chronic central lines in pediatric hematology/oncology patients. The Control Arm will involve "usual care" for ambulatory central lines per institutional policy and the Intervention Arm will add use of 70% isopropyl alcohol embedded protective caps to "usual care. Each participating institution will be randomly assigned to either the intervention or control phase of the design for the first 12 months of the study. There will then be a 3 month wash out period, followed by each institution then implementing either the control or intervention phase for another 12 months such that each institution will complete 12 months each in the intervention arm and the control arms of the study.

Sixteen pediatric hematology/oncology institutions will serve as the core population for this proposal and unit of randomization. All ambulatory patients taken care of by these pediatric hematology/oncology clinics at these institutions will be eligible for this study. The only inclusion criteria will be presence of an external central line. Given the intervention is a protective cap for central line access ports, patients who only have a totally implanted port as their central venous access will not be eligible for this study as the intervention is not physically applicable to such central lines.

The intervention the investigators will deploy is the CUROS® brand of 70% isopropyl alcohol embedded protective caps for central lines. These caps are manufactured by Ivera Medical Corporation. As in kind contribution to this proposed study, Ivera Medical Corporation has agreed to donate and distribute all needed CUROS® caps to the participating institutions for the duration of this study. If any of the participating teams wishes to instead use a comparable brand of 70% isopropyl alcohol embedded protective caps for central lines that will be permitted.

Distribution of the CUROS® caps will be accomplished within the clinics of each participating institution and compliance with the intervention at homes will be monitored by clinic staff via tracking counts of CUROS® caps dispensed to families. Children with chronic hematologic/oncologic conditions are seen frequently in clinic, often up to every week. Clinic staff can distribute and track volume of CUROS® caps dispensed to each family/patient, with the family/patient can report back each visit on the volume of CUROS® caps utilized. This will ensure reliable distribution to the families/patients, provide a face to face educational opportunity to ensure proper application of the CUROS® cap, and provide compliance opportunities via counts of CUROS® caps utilized.

This proposal will involve a cluster-randomized, 2 period crossover design, clinical trial. Given this proposal's focus on reducing central line infections at home, the main facilitators of best practice use of these caps at home will be the families and patients themselves. The research team will spread the needed additional education, tools, data, analyses, and support for this proposal.

Study Organization and Timeline: The work will build on the partnership between the pediatric quality improvement research group at Johns Hopkins University and the vendor Ivera Medical Corporation, maker of the CUROS® brand 70% isopropyl alcohol embedded protective caps for central lines. Dr. Miller is Principal Investigator and serves as Vice Chair of Quality and Safety, Director of Division of Quality and Safety at the Johns Hopkins Children's Center. Dr. Miller had led and continues to lead efforts to transform the quality and safety of the delivery system at Johns Hopkins University and is a formally trained in Lean Six Sigma quality improvement as well as having her Masters of Science degree in clinical research. In addition, Dr. Aaron Milstone at Johns Hopkins University, director of pediatric hospital epidemiology and infection control and an accomplished researcher in pediatric infection prevention, will be a Co-Investigator on this proposal. Dr. Milstone led the recently published clinical trial work in Lancet describing the impact of chlorhexidine bathing on CLABSI and positive blood cultures in children in 10 PICUs. Dr. Elizabeth Colantuoni is a Biostatistician and Assistant Scientist in the Johns Hopkins Bloomberg School of Public Health.

The work will span four years. Year 1 Preparatory work will include establishing Institutional Review Board approval at each of the participating institutions, setting up data collection and submission processes, setting up distribution mechanisms for the intervention both to the clinics and then within each clinic to the homes, and educating providers, patients, and families on how to apply the CUROS® cap across all the participating institutions. Years 2, 3, and 4 will include two 12 month trial periods with a 3 month wash out period in between. The last 9 months of Year 4 will be used for data analysis and manuscript preparation.

Methods SPECIFIC AIM 1 and SPECIFIC AIM 2:

Specific Aim #1: Evaluate whether use of 70% isopropyl alcohol embedded protective caps on central lines reduces the rate of CLABSI in ambulatory pediatric hematology/oncology patients.

Hypothesis: Use of 70% isopropyl alcohol embedded protective caps on central lines will be associated with at least a 25% reduction in the ambulatory CLABSI rate for pediatric hematology/oncology patients.

Specific Aim #2: Evaluate whether use of 70% isopropyl alcohol embedded protective caps on central lines reduces the rate of all positive blood cultures in ambulatory pediatric hematology/oncology patients.

Hypothesis: Use of 70% isopropyl alcohol embedded protective caps on central lines will be associated with at least a 25% reduction in the positive blood culture rate at home for pediatric hematology/oncology patients.

Independent variables: The primary independent variable will be ambulatory CLABSI rates for Specific Aim #1 and all positive blood culture rates, defined as CLABSI rate + MBI-CLABSI rates + Secondary BSI rates + single positive blood culture (SPBC) rates, for Specific Aim #2. All of the participating units already devote Hospital Infection Control staff to identify and track all 3 of these types of ambulatory central line infections.

Dependent variable: The dependent variable for these Specific Aims will be the dichotomous assignment to either control or intervention arms where unit will receive both arms.

Data collection method: All Hematology/Oncology units will submit monthly aggregate clinic data on CLABSI, MBI-CLABSI, Secondary BSI and SPBC (numerators and denominators) via a web-based data entry tool.

Exploratory analyses: Events and line-days at the unit level will be calculated to summarize rates of infections (CLABSI and all infections) by treatment and period as well as by month to assess for any important trends. These trends will be evaluated using scatterplots and line plots, overall and separately by treatment arm and period. Summary statistics, such as mean, median, interquartile range and variance, for the monthly number of infection events and rates will be calculated for the overall sample and by treatment and period. In case missing data occurs in our analysis we will explore the relationship between missing data and the unit's observed data in months prior and our analysis methods will be valid under the assumptions that the missing data are generated completely at random or depend on the prior observed rates (missing at random). Our data integrity efforts and frequent contacts with this team will work to minimize any instances of missing data.

Multivariate analyses: Random effects Poisson regression models will be used to test for a treatment effect. Specifically, the monthly number of CLABSI (Specific Aim #1) or the monthly number of all infections (Specific Aim #2) will be modeled as a function of the dichotomous treatment assignment and an indicator for when the treatment arm was received (first or second 12 month period) with inclusion of an offset representing the monthly number of central line days and a random intercept for unit to account for the correlation of monthly rates of infections over time within the same unit. The models rely on two key assumptions: i) the infection rates follow a Poisson distribution where the mean rate is the same as the variance in the rate and ii) the correlation of the rates within a unit over time is exchangeable. These assumptions will be assessed via descriptive analyses and by adding a robust variance estimate clustering on the unit.

Methods, Specific Aim #3: To evaluate whether the use of 70% isopropyl alcohol embedded protective caps on central lines changes the distribution of bacteria isolated from blood cultures of ambulatory pediatric hematology/oncology patients.

Hypothesis: Use of 70% isopropyl alcohol embedded protective caps on central lines will be associated with altered microbial epidemiology for CLABSI, secondary blood steam infections, and single positive blood cultures at home for pediatric hematology/oncology patients.

Independent variables: Organisms isolated for all blood cultures (CLABSI + MBI-CLABSI + Secondary BSI + SPBC) in patients involved in this study will be collected from participating teams during both the Control and Intervention arms of the clinical trial and sorted into Gram Positive versus Gram Negative organisms.

Dependent variable: The dependent variable for this Specific Aim will be the dichotomous assignment to either control or intervention arms.

Data collection method: All Hematology/Oncology ambulatory care teams will submit the microbial pattern data for all positive blood cultures.

Analyses: The analysis would be a comparison of proportions of Gram positive organisms causing CLABSI, SPBC, and all positive blood cultures between the control and intervention study arms. Given that Gram positive organisms are the most common organisms causing CLABSI and SPBC in children, achieving a reduction in Gram positive organisms would be an important additional finding of this clinical trial.

Community Central Line Infection Prevention Trial

Participating individuals are at the hospital level via hospital ambulatory central line infection rates

To obtain rate of ambulatory central line associated blood stream infections in ambulatory patients

To obtain rate of ambulatory Mucosal Barrier Injury central line-associated bloodstream infections (MBI-CLABSI)

To obtain rate of ambulatory secondary bloodstream infections

To obtain rate of ambulatory single positive blood culture (SPBC)

To obtain rate of ambulatory positive blood culture rate

Organism distribution of Gram positive bacteria, Gram negative bacteria, fungi, or other.

Agency for Healthcare Research and Quality (AHRQ)

Johns Hopkins University

Clinics were asked to report any Adverse Events if they occurred and no Adverse Events were reported. The at Risk is entered as 0 because the precise number of participants from each clinic is unknown.

All 16 clinics included in this cluster-randomized trial.

All Clinics

< 2 years

2 - 5 years

6 - 11 years

≥ 12 years

Data collected and reported reflect the median percentage of participants across all clinics for each age category in the data table.

Age, Customized

Female

Male

Sex/Gender, Customized

Number of inpatient pediatric oncology beds

Number of annual pediatric oncology admissions

Number of pediatric oncology ambulatory visits

Number of total inpatient days

Number of total Bone Marrow Transplant/Stem Cell

Number of participants is not available for this study, only clinic-level data collected.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study to Extend the Maximum Maintenance Flushing Interval for Ports With Distally Valved Catheters	NCT01586026	Cancer		21 Years -	C. R. Bard
Post-thrombotic Syndrome & Predictors of Recurrence in Catheter-related Thrombosis	NCT01999179	Venous Thrombos... Neoplasms	Heparin, Low-Mo...	18 Years -	Medical College of Wisconsin
Study of the Impact of Frequency of Changing PICCline Dressings in Patients With Acute Leukemia	NCT05793801	Leukemia	Dressing change	18 Years -	Centre Hospitalier Universitaire de Nīmes
Study of the Impact of Frequency of Changing PICCline Dressings in Patients With Acute Leukemia	NCT05793801	Leukemia	Dressing change	18 Years -	Centre Hospitalier Universitaire de Nīmes
Community Central Line Infection Prevention Trial	NCT02351258	Infection	70% Isopropyl a... Usual Care	1 Day - 35 Years	Johns Hopkins University
Complications and Risk Factors Related With Central Venous Catheters in Cancer Patients	NCT01661218	Thrombosis Infections		18 Years -	Beijing Huanxing Cancer Hospital
Study of the Impact of Frequency of Changing PICCline Dressings in Patients With Acute Leukemia	NCT05793801	Leukemia	Dressing change	18 Years -	Centre Hospitalier Universitaire de Nīmes

Spots Global Cancer Trial Database for catheters

Every month we try and update this database with for catheters cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for catheters

Every month we try and update this database with for catheters cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for catheters cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.