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

Antipyretics

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Platelet Aggregation Inhibitors

Aspirin

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase Inhibitors

Rivaroxaban 10mg

Aspirin 100mg

low molecule heparin

Jian Huang, Doctor

Gui Nv Hu, Doctor

Wen J Chen, Doctor

Pei F Fu, Doctor

Zhi Y Feng

Zhen Y Wang, Doctor

Jing P Long, Doctor

Xiao H Xie, Doctor

Gui P Chen, Doctor

Xiao C Wang, Doctor

Shi L Tu, Doctor

Yun H Wei, Doctor

Shu Z Fang, Doctor

Juan Y Zhu, Doctor

Shu G Li, Doctor

Shu Z Chen, Doctor

Qing H Shen, Doctor

Yong Shi, Doctor

Yi J Mei, Doctor

Jia M Lei, Doctor

Lv J Cen, Doctor

Yan Zhang, Doctor

Ying J Wu, Doctor

Zhan W Li, Doctor

Jian Zhang, Doctor

Ou C Wang, Doctor

Min Zheng, Doctor

Jing Xu, Doctor

The main objective of this study is to compare the efficacy and safety of aspirin, low molecule heparin and rivaroxaban for preventing catheter-related thrombosis in middle-to-high-risk ambulatory patients with cancer and implantable venous access ports.

Study Type: Interventional, randomized, parallel Assignment and no masking

Study Arms \& Intervention: Drug 1: Aspirin, 100mg/day orally; Drug 2: rivaroxaban, 10mg/day orally; Drug 3: low molecule heparin, 4000IU(0.4ml)/day subcutaneous injection; Reference: mechanical prophylaxis.

Follow-up Period: 6 months. The trial visits occurred at time before each chemotherapy cycle. The following details should be included at each visit: Khorana score, height and weight, blood routine examination, coagulation function, stool-routine and occult blood test, renal and liver function, ultrasonography of both legs and neck.

Primary Outcome: The primary efficacy end point was the occurrence of thrombus in the vein at the puncture site or nearby. The primary was the occurrence of a major bleeding event as defined by the International Society on Thrombosis and Haemostasis (ISTH).

Secondary Outcome: The secondary efficacy end point was occurrence of occurrence of other thrombosis or embolism events like deep vein thrombosis or pulmonary embolism. The secondary safety endpoint was the occurrence of any clinically relevant non-major bleeding, minor bleeding and adverse events.

Population: patients with cancer and implantable venous access ports

Eligibility Criteria:

1. Age 18-75 years;
2. Patients with malignant tumors who received implantable drug delivery devices as intravenous access for systematic chemotherapy;
3. Eastern Cooperative Oncology Group (ECOG) class 0-1;
4. Expected to receive chemotherapy within 1 week of enrollment;
5. Expected survival of more than 6 months;
6. Ambulatory patients or outpatient chemotherapy patients whose intravenous chemotherapy less than 24 hours per hospital stay;
7. Khorana score 1-3 point.

Exclusion Criteria:

1. Patients with a history of allergies to low molecular weight heparin, rivaroxaban, aspirin or other non-steroidal anti-inflammatory drugs, especially those with asthma, neurovascular edema or shock;
2. Patients with bleeding risks: thrombocytopenia (platelet count \< 50\*109/L), clinically significant active bleeding, active gastric ulcer disease, severe arterial hypertension, history of previous stroke;
3. moderate to severe liver and kidney dysfunction;
4. pregnant or lactating women;
5. patients who are administered systemically with pyrrole-antimycotic agents (eg ketoconazole, itraconazole, voriconazole and posaconazole) or HIV protease inhibitors (eg ritonavir);
6. Patients taking methotrexate;
7. Patients with systemic use of non-steroidal anti-inflammatory drugs;
8. Patients who have had anticoagulant drugs for any other reason.

Prophylactic Anticoagulation for Catheter-related Thrombosis

The Efficacy and Safety of Prophylactic Anticoagulation for Catheter-related Thrombosis in Patients With Cancer and Implantable Venous Access Ports: a Prospective Multi-center Randomized Controlled Trial.

detect the occurrence of catheter-related thrombosis with ultrasound, venography if necessary

define occurrence of major-bleeding event with ISTH standard

detect deep vein thrombosis with ultrasound for the lower extremity, , ultrasound for the upper extremity, pulmonary arteriography or venography if necessary

define occurrence of non-major-bleeding or minor-bleeding event with ISTH standard, evaluate the relevant adverse drug reaction with NCI CTCAE 5.0

Second Affiliated Hospital, School of Medicine, Zhejiang University

Skin and Connective Tissue Diseases

Diseases and Abnormalities at or Before Birth

Breast Neoplasms

Neoplasm Metastasis

Congenital Abnormalities

Upper Extremity Deep Vein Thrombosis

Breast Diseases

Skin Diseases

Philippe M Debourdeau, MD

In order to avoid to use a traumatic and iatrogenic examen (phlebography), the purpose of the study is to validate echography doppler in the diagnosis of asymptomatic related catheter related thrombosis.

Phlebography is the gold standard for the diagnosis of asymptomatic catheter related thrombosis but can not be performed in about 15% of patients because of arm swelling and lack of superficial veins.

Echography doppler is an easy, cheap and atraumatic way to make the diagnosis of deep vein thrombosis. The value of echography doppler has been proven for the diagnosis of symptomatic deep venous thrombosis of lower and upper limbs and for the diagnosis of proximal asymptomatic lower limbs.

To validate the echography doppler we intend to correlate asymptomatic findings to the occurrence symptomatic related catheter related thrombosis.

Patients with localized breast cancer treated with chemotherapy will be enrolled in the study. An echography doppler will be performed on day 8, 30 and 90 after catheter insertion. Findings in asymptomatic patients (thrombus visualisation, lack of vein compressibility, variation of physiologic vein blood flow) will thereafter be correlated with the presence or absence of clinical signs of catheter related thrombosis.

In order to assess if they are risk factors for catheter related thrombosis, we will determine the level D-Dimer, microparticles and the results of generation thrombin tests before and 2 days after catheter insertion.

Determination of Predictive Value of Echography Doppler Abnormalities

CAVECCAS Value of Risk Factors for Symptomatic Catheter Related Thrombosis in Patients With Breast Cancer Treated With Adjuvant Chemotherapy

Assistance Publique - Hôpitaux de Paris

Isabelle Brindel

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
Prophylactic Anticoagulation for Catheter-related Thrombosis	NCT04256525	Venous Thrombos... Prophylactic An... Patients With T...	Rivaroxaban 10m... Aspirin 100mg low molecule he...	18 Years - 75 Years	Second Affiliated Hospital, School of Medicine, Zhejiang University
Determination of Predictive Value of Echography Doppler Abnormalities	NCT00714909	Breast Cancer Upper Extremity...		18 Years - 80 Years	Assistance Publique - Hôpitaux de Paris
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 catheter related thrombosis