Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prophylactic Anticoagulation for Catheter-related Thrombosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04256525
Recruitment Status : Not yet recruiting
First Posted : February 5, 2020
Last Update Posted : March 26, 2020
Sponsor:
Information provided by (Responsible Party):
Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Venous Thrombosis Due to Central Venous Access Device (Disorder) Prophylactic Anticoagulation Patients With Tumor Drug: Rivaroxaban 10mg Drug: Aspirin 100mg Drug: low molecule heparin Phase 4

Detailed Description:

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1640 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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.
Estimated Study Start Date : May 1, 2020
Estimated Primary Completion Date : August 30, 2021
Estimated Study Completion Date : February 28, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Aspirin 100mg Drug: Aspirin 100mg
100mg orally per day

Experimental: rivaroxaban 10mg Drug: Rivaroxaban 10mg
10mg orally per day

Experimental: low molecule heparin Drug: low molecule heparin
0.4ml per day subcutaneous injection

No Intervention: Reference
mechanical prophylaxis



Primary Outcome Measures :
  1. occurrence of catheter-related thrombosis [ Time Frame: from enrollment to the first time of occurrence of catheter-related thrombosis, up to 1 month after the completion of last chemotherapy cycle ]
    detect the occurrence of catheter-related thrombosis with ultrasound, venography if necessary

  2. occurrence of major-bleeding event [ Time Frame: from enrollment to the first time of occurrence of major-bleeding event, up to 1 month after the completion of last chemotherapy cycle ]
    define occurrence of major-bleeding event with ISTH standard


Secondary Outcome Measures :
  1. occurrence of other thrombosis or embolism events except for catheter-related thrombosis [ Time Frame: from enrollment to the first time of occurrence of other thrombosis or embolism events except for catheter-related thrombosis , up to 1 month after the completion of last chemotherapy cycle ]
    detect deep vein thrombosis with ultrasound for the lower extremity, , ultrasound for the upper extremity, pulmonary arteriography or venography if necessary

  2. occurrence of clinically relevant non-major-bleeding, minor-bleeding or non-bleeding event [ Time Frame: from enrollment to the first time of occurrence of events, up to 1 month after the completion of last chemotherapy cycle ]
    define occurrence of non-major-bleeding or minor-bleeding event with ISTH standard, evaluate the relevant adverse drug reaction with NCI CTCAE 5.0



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04256525


Contacts
Layout table for location contacts
Contact: Jian Huang, Doctor 13958123068 hjys@zju.edu.cn

Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University

Layout table for additonal information
Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT04256525    
Other Study ID Numbers: Research 2019-400
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: March 26, 2020
Last Verified: January 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University:
implantable venous access ports
Catheter Related thrombosis
thromboprophylaxis
anticoagulants
aspirin
low molecule heparin
rivaroxaban
cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Aspirin
Heparin
Calcium heparin
Rivaroxaban
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Anticoagulants
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors