Managing blood clot prevention in cancer patients with catheter-related DVT
Secondary Prevention of Venous Thromboembolism in Patients With Cancer and Catheter-Related Upper Extremity Deep Vein Thrombosis (STREAM-Line Study)
This study is testing whether giving a low dose of a blood thinner to cancer patients with a history of blood clots can help prevent new clots from forming.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 330 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ottawa Hospital Research Institute Academic / other |
| Locations | 1 site (Ottawa, Ontario) |
| Trial ID | NCT06603870 on ClinicalTrials.gov |
What this trial studies
This trial evaluates a management strategy for patients with cancer who have experienced catheter-related upper extremity deep vein thrombosis (DVT) after completing at least three months of therapeutic anticoagulation. The STREAM-Line management strategy involves administering a prophylactic dose of apixaban to prevent further clot formation as long as the patient has an active cancer or a central venous catheter. Follow-up assessments will occur at 90 and 180 days to monitor safety and efficacy. The goal is to determine the safety of this approach in preventing recurrent DVT in this high-risk population.
Who should consider this trial
Good fit: Ideal candidates are adults with active cancer and confirmed catheter-related upper extremity DVT who have completed at least three months of therapeutic anticoagulation.
Not a fit: Patients with active bleeding or contraindications to anticoagulation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer management strategy for preventing recurrent blood clots in cancer patients with catheter-related DVT.
How similar studies have performed: Other studies have shown promising results with prophylactic anticoagulation strategies in similar patient populations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adult patients (≥ 18 years old) with active cancer, defined as cancer (other than localized non-melanoma skin cancer) diagnosed or treated within 6 months, or the presence of metastatic, recurrent, or progressive malignancy, ongoing anticancer therapy, or hematological malignancy not in complete remission. 2. Objectively confirmed catheter-related upper extremity DVT and treated with any standard therapeutic anticoagulation (including LMWH dose reduction to 75% after the first month) for at least 3 months. 3. Able and willing to provide informed consent. Exclusion Criteria: 1. Active bleeding or other reasons for which anticoagulation is contraindicated. 2. Other indications requiring ongoing therapeutic dose of anticoagulation as deemed necessary by treating physicians (such as atrial fibrillation, mechanical heart valve, etc.). 3. Anticoagulation has been permanently stopped or reduced to prophylactic dose prior to enrollment for any reasons, except for participants who were transitioned to apixaban dosing regimen consistent with the protocol (2.5 mg twice daily) for ≤ 3 days . 4. Known contraindication for apixaban, such as allergy, hypersensitivity, or pregnancy. 5. Concomitant use of strong inhibitors or inducers of both cytochrome P450 3A4 (enzyme) and P-glycoprotein.
Where this trial is running
Ottawa, Ontario
- The Ottawa Hospital — Ottawa, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Tzu-Fei Wang, MD, MPH — Ottawa Hospital Research Institute
- Study coordinator: Tzu-Fei Wang, MD, MPH
- Email: tzwang@toh.ca
- Phone: 6137379988
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.