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Prophylactic Anticoagulation for Catheter-related Thrombosis

Zhejiang University logo

Zhejiang University

Status and phase

Unknown
Phase 4

Conditions

Prophylactic Anticoagulation
Venous Thrombosis Due to Central Venous Access Device (Disorder)
Patients With Tumor

Treatments

Drug: low molecule heparin
Drug: Rivaroxaban 10mg
Drug: Aspirin 100mg

Study type

Interventional

Funder types

Other

Identifiers

NCT04256525
Research 2019-400

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,640 estimated patients

Sex

Female

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,640 participants in 4 patient groups

Aspirin 100mg
Experimental group
Treatment:
Drug: Aspirin 100mg
rivaroxaban 10mg
Experimental group
Treatment:
Drug: Rivaroxaban 10mg
low molecule heparin
Experimental group
Treatment:
Drug: low molecule heparin
Reference
No Intervention group
Description:
mechanical prophylaxis

Trial contacts and locations

24

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Central trial contact

Jian Huang, Doctor

Data sourced from clinicaltrials.gov

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