Infections

All Conditions

Heart and Blood Diseases

Neoplasms

Blood and Lymph Conditions

Symptoms and General Pathology

Thrombosis

Hematologic Neoplasms

Communicable Diseases

Bacteremia

Catheter-Related Infections

Embolism

Embolism and Thrombosis

Vascular Diseases

Hematologic Diseases

Bacterial Infections

Mycoses

Bacterial Infections and Mycoses

Sepsis

Toxemia

Syndrome

Systemic Inflammatory Response Syndrome

Inflammation

Fibrinolytic Agents

Anticoagulants

All Drugs and Chemicals

Other Dietary Supplements

Heparin

Citric Acid

Sodium Citrate

Calcium heparin

Citrate

After each use, the central venous catheter lumen will be flushed with 10 ml 0.9% NaCl and then locked with heparin 5000 IU/ml(standard treatment)using a volume exactly equivalent to the internal volume noted on each catheter.

locking the central venous catheter with concentrated citrate after each use

when not in use CVCs are locked with heparin

heparin

when not in use the CVC is locked with concentrated citrate

concentrated citrate

Harry Schouten, MD

Patients with a hematological malignancy who are undergoing intensive chemotherapy need a central venous catheter (CVC)during their treatment. CVCs are locked with heparin when they are not used.

The purpose of this study is to determine whether concentrated citrate locking, compared to heparin, reduces the incidence of central venous catheter-related thrombosis and infections in patients with hematological malignancies undergoing intensive chemotherapy.

Central venous catheter (CVC)-related thrombosis and infections are frequently occurring complications and may cause significant morbidity in patients with hematological malignancies. Interventions to decrease fibrin deposition have the potential to reduce CVC-related thrombosis and infections.

At present heparin is most often used as locking solution for central venous catheters in hematological patients despite a lack of evidence regarding the efficacy and safety. Trisodium citrate (TSC) had been shown to be an effective antimicrobial catheter locking in hemodialysis patients.

Concentrated Citrate Locking to Reduce the Incidence of CVC-related Complications in Hematological Patients

Concentrated Citrate Locking to Reduce the Incidence of Central Venous Catheter-related Infections and Thrombosis: a Randomized Phase III Study in a Hematological Patient Population

Patients will be followed from insertion of the central venous catheter till removal of the central venous catheter, an expected average of 30 days. The central venous catheter is seen daily and checked for thrombosis and infections when the patient is admitted on the ward. Discharged patients are seen at least weekly on the outpatients clinic and their central venous catheter is checked for thrombosis and infections. A standard ultrasound is made 30 days after insertion and within 24 hours after removal of the central venous catheter.

Dirinco B.V.

Maastricht University Medical Center

Recurrence

Venous Thrombosis

Postthrombotic Syndrome

Postphlebitic Syndrome

Disease Attributes

Venous Insufficiency

Phlebitis

Peripheral Arterial Disease

Peripheral Vascular Diseases

Anti-Infective Agents

Amino Acids

Enoxaparin

Edoxaban

Rivaroxaban

Apixaban

Dabigatran

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

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

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

Overall Study

Pharmaceutical Solutions

Patients diagnosed with asymptomatic catheter-related DVT who are randomized to treatment with enoxaparin for 6 weeks

Patients diagnosed with asymptomatic catheter-related DVT who are randomized to close observation for 6 weeks

Lovenox ® is a sterile aqueous solution containing enoxaparin sodium, a low molecular weight heparin. It is given as a subcutaneous injection twice daily. Dose of enoxaparin (Lovenox ®) will be 1 mg/kg every 12 hours for children \>2 months and 1.5 mg/kg every 12 hours for infants \<2 months. Duration of treatment is 6 weeks.

Janna Journeycake, MD

The primary hypothesis of this study is that occult catheter-related DVT in children with cancer is common and directly contributes to development of serious catheter complications, specifically bacteremia/fungemia and/or recurrent occlusion of the catheter tip. Accordingly, anticoagulant treatment of clinically silent (occult) DVT will reduce rates of catheter-related infection and occlusion, delays in therapy and need for catheter replacement.

This is a two-part study with an initial diagnosis component followed by a treatment component. The number of subjects to be consented for the diagnosis component is 350, and 50 for the treatment portion (25 on the observation arm, and 25 for enoxaparin treatment).

Study Procedures:

Patients diagnosed with cancer at the Center for Cancer and Blood Disorders will have a catheter inserted for cancer related treatment. After insertion, eligible patients who provide consent will be enrolled in the diagnosis component of the study. The principal investigator and research team will monitor for catheter complications (occlusion and bacteremia/fungemia). After two complications, participants will be screened for occult central venous catheter (CVC)-related DVT by contrast venography, ultrasonography, or magnetic resonance venography. If DVT is not diagnosed, participant will go off the study. If DVT is diagnosed, participant will be asked to consent to enroll in the treatment study. After enrollment, participant is randomized between the two arms of observation and enoxaparin treatment. After 6 weeks, patients will have another image; this represents the end of treatment period. After the follow-up imaging, patients will be monitored for 10 weeks to obtain primary outcomes. Once a primary outcome (progression to symptomatic DVT or pulmonary embolism (PE), blood stream infection or catheter removal) is achieved the participants can be treated with anticoagulation again if necessary, but primary oncologist will determine treatment.

Analysis:

The hypothesis is that the enoxaparin treatment group will have a median adverse catheter event free survival time of 12 weeks versus 4 weeks for the control group with a hazard ration of 0.4. A total sample size of 50 (25 in each arm) will detect such a difference with 90% power at an α=0.05. If there is a drop out rate of 10% in each arm, a difference can still be detected with 80% power.

Approximately 200 to 250 patients are diagnosed with cancer each year at Children's Medical Center Dallas, and based on prior institutional experience, two-thirds will have catheters inserted to facilitate chemotherapy. However, one-quarter of these patients have brain tumors and are not eligible due to the potential increased risk of intracranial hemorrhage with anticoagulation. There will be 100 patients each year who are at risk for CVC-related DVT. Based on previous studies, up to 50% of patients should develop occult DVT; however, only 35% of patients will likely be screened with radiographic imaging. Approximately 17 patients a year enrolled in the diagnosis study may be diagnosed with DVT and eligible for randomization. Therefore, total enrollment will be completed in approximately 3 years with an additional 4 months necessary to complete the follow-up period.

Identification and Treatment of Clinically Silent Catheter-Related Deep Vein Thrombosis in Children With Cancer

Phase II Study on the Identification and Treatment of Clinically Silent Catheter-Related Deep Vein Thrombosis in Children With Cancer

catheter removal, signs and symptoms of DVT or PE, OR bacteremia/fungemia

Bleeding complications associated with enoxaparin therapy, need for additional platelets

University of Texas Southwestern Medical Center

Patients \</=18 years of age with cancer and a first indwelling catheter expected to be in place for 3 months are enrolled. They are screened with either contrast venogram or ultrasound for asymptomatic catheter-related DVT if they have had at least 2 complications including line occlusion requiring thrombolysis or catheter infection that did not result in removal of the line. If they have a positive screening study they are eligible for Arm B

A-Prospective Screening for Asymptomatic Catheter-related DVT

Patients diagnosed with asymptomatic catheter-related DVT who are randomized to close observation vs enoxaparin for 6 weeks

B-Randomized Clinical Trial

Patients diagnosed with asymptomatic catheter-related DVT who are randomized to treatment with enoxaparin for 6 weeks

Enoxaparin: Lovenox ® is a sterile aqueous solution containing enoxaparin sodium, a low molecular weight heparin. It is given as a subcutaneous injection twice daily. Dose of enoxaparin (Lovenox ®) will be 1 mg/kg every 12 hours for children \>2 months and 1.5 mg/kg every 12 hours for infants \<2 months. Duration of treatment is 6 weeks.

A-Prosepctive Screeing for Asymptomatic DVT

B-Randomized Clinical Trail for Treatment

Total

Age, Categorical

No patient from arm A was eligible to enroll in Arm B.

Study terminated early for lack of accrual on Arm B (randomized trial). No patient enrolled on Arm A (screening study) were eligible. Standard treatment of asymptomatic catheter-related DVT changed in 2010, favoring treatment with enoxaparin.

A- Prospective Screening for Asymptomatic Catheter-related DVT

Patients diagnosed with asymptomatic catheter-related DVT who are randomized to close observation or treatment with enoxaparin

No patient was enrolled on the randomized clinical trial (arm B) after being on the prospective screening trial (Arm A)

Composite Endpoint for Arm B of the Study: Catheter Removal, Signs and Symptoms of DVT or PE, OR Bacteremia/Fungemia

A: Prospectvie Screening for Asymptomatic Catheter-related DVT

Patients diagnosed with asymptomatic catheter-related DVT who are randomized to close observation or enoxaparin to treat asymptomatic DVT

B-randomized Treatment Trail

Since no patient was enrolled on Arm B of this study, there is no analysis of bleeding.

Bleeding Complications Associated With Enoxaparin Therapy, Need for Additional Platelets

Patients \</=18 years of age with cancer and a first indwelling catheter expected to be in place for 3 months are enrolled. They are screened with either contrast venogram or ultrasound for asymptomatic catheter-related DVT if they have had at least 2 complications including line occlusion requiring tpa or catheter infection that did not result in removal of the line. If they have a positive screening study they are eligible for Arm B

A-Prosepctive Screening for Asymptomatic DVT

Patients diagnosed with asymptomatic catheter-related DVT who are randomized to between enoxaparin or close observation for 6 weeks

Rajesh V Lalla, DDS, Ph.D

Patients who are preparing to receive chemotherapy are asked to have their teeth cleaned before starting treatment as standard of care. This research study is being done to see if having dental cleaning increases the chances of bacteria from the mouth getting into the blood stream. It is also being done to see if these bacteria can cause blood stream infections in people who have a Central Venous Catheter (CVC),often called a "port" or a "PICC", placed for giving chemotherapy. It is a well-established fact that we introduce bacteria from the mouth into the bloodstream with activities of daily life including chewing, flossing and brushing teeth. This introduction of bacteria into the blood stream may cause bacteria to stick to the central venous catheter and serve as a source of infection when the immune system is weakened by cancer. The purpose of this research study is to see if we can find bacteria from mouth in blood that is drawn through the CVC, during, and after a dental cleaning procedure. This way, we will be able to assess whether or not this is a potential health risk to cancer patients.

Dental Study in Cancer Patients With Central Venous Catheters

Pilot Study on Transient Bacteremia and Blood Stream Infections After Invasive Dental Procedures in Cancer Patients With Central Venous Catheters

Blood cultures drawn before dental cleaning, 20 minutes after starting procedure, 30 minutes after finishing the procedure and at 24 hours after starting the procedure. Records reviewed at one month and six months post procedure for bloodstream or central venous catheter infection.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Concentrated Citrate Locking to Reduce the Incidence of CVC-related Complications in Hematological Patients	NCT01820962	Hematological M... Bacteremia Thrombosis	heparin concentrated ci...	18 Years -	Maastricht University Medical Center
Post-thrombotic Syndrome & Predictors of Recurrence in Catheter-related Thrombosis	NCT01999179	Venous Thrombos... Neoplasms	Heparin, Low-Mo...	18 Years -	Medical College of Wisconsin
Identification and Treatment of Clinically Silent Catheter-Related Deep Vein Thrombosis in Children With Cancer	NCT00633061	Childhood Cance... Central Venous ... Deep Vein Throm... Catheter-relate... Catheter-relate...	Enoxaparin	- 18 Years	University of Texas Southwestern Medical Center
Dental Study in Cancer Patients With Central Venous Catheters	NCT00798330	Cancer		18 Years -	UConn Health
Concentrated Citrate Locking to Reduce the Incidence of CVC-related Complications in Hematological Patients	NCT01820962	Hematological M... Bacteremia Thrombosis	heparin concentrated ci...	18 Years -	Maastricht University Medical Center

Spots Global Cancer Trial Database for central venous catheters