Clinical Trials Directory

Trials / Recruiting

RecruitingNCT06603870

Secondary Prevention of VTE in Patients With Cancer and Catheter-Related Upper Extremity Deep Vein Thrombosis

Secondary Prevention of Venous Thromboembolism in Patients With Cancer and Catheter-Related Upper Extremity Deep Vein Thrombosis (STREAM-Line Study)

Status
Recruiting
Phase
Phase 4
Study type
Interventional
Enrollment
330 (estimated)
Sponsor
Ottawa Hospital Research Institute · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This trial seeks to evaluate a management strategy after the acute treatment duration (≥ 3 months of therapeutic anticoagulation) for patients with cancer and catheter-related upper extremity deep vein thrombosis (DVT).

Detailed description

The aim of the STREAM-Line Trial is to demonstrate that the STREAM-Line management strategy is safe after the acute treatment duration (≥ 3 months of therapeutic anticoagulation) in patients with cancer and catheter-related upper extremity DVT. Upon enrollment and during follow-up, patients will be managed with a prophylactic dose of apixaban (2.5 mg orally twice daily) as long as either a central venous catheter (CVC) or active cancer is present (STREAM-Line management strategy). Apixaban will be stopped at the time of CVC removal and when cancer is in remission. Day 90±14 and Day 180+14 follow-up visit procedures will be done by phone call or in person.

Conditions

Interventions

TypeNameDescription
DRUGApixabanApixaban is Health Canada approved for routine treatment and secondary prevention of VTE. Upon enrollment and during follow-up, patients will be managed with a prophylactic dose of apixaban (2.5 mg orally twice daily) as long as either a CVC or active cancer is present. Apixaban will be stopped at the time of CVC removal and when cancer is in remission. Patients will be instructed to contact the study team when their CVC is removed (to determine if apixaban should be continued, based on cancer status at the time), or any thrombotic or bleeding concerns were to occur in between visits. The investigators will record loss to follow-up, drop out, or death during the study.

Timeline

Start date
2024-12-19
Primary completion
2029-10-01
Completion
2029-10-01
First posted
2024-09-19
Last updated
2025-05-30

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT06603870. Inclusion in this directory is not an endorsement.