Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apixaban | Experimental | 2.5 mg twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apixaban | Drug | Apixaban 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Venous Thromboembolism (VTE) Rate | The rates of symptomatic, objectively confirmed new or recurrent major VTE (proximal upper or lower extremity DVT, segmental or larger pulmonary embolism (PE)) with corresponding 95% Confidence Interval (CI) at 6 months. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Major Venous Thromboembolism (VTE) and Major bleeding Rate | Rates of new/recurrent symptomatic major VTE and major bleeding at 3 months. | 3 months |
| New/recurrent symptomatic catheter-related upper extremity Deep Vein Thrombosis (DVT). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tzu-Fei Wang, MD, MPH | Contact | 6137379988 | 73755 | tzwang@toh.ca |
| Name | Affiliation | Role |
|---|---|---|
| Tzu-Fei Wang, MD, MPH | Ottawa Hospital Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ottawa Hospital | Recruiting | Ottawa | Ontario | K1H 8L6 | Canada |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Apixaban 2.5 mg twice daily
Not provided
Not provided
Not provided
Not provided
|
New/recurrent symptomatic catheter-related upper extremity DVT.
| 3 months and 6 months |
| New incidental Venous Thromboembolism (VTE) | New incidental VTE (PE or upper or lower extremity DVT), defined as VTE diagnosed on imaging studies obtained not for concern of VTE, such as cancer staging scans. | 3 months and 6 months |
| New Deep Vein Thrombosis (DVT) | New/recurrent any distal upper or lower extremity DVT or subsegmental PE. | 3 months and 6 months |
| Superficial vein thrombosis of upper or lower extremities | Superficial vein thrombosis of upper or lower extremities | 3 months and 6 months |
| New unusual site Venous Thromboembolism (VTE) | New unusual site VTE (such as splanchnic vein, cerebral vein, or gonadal vein thrombosis). | 3 months and 6 months |
| Clinically Relevant Non-Major Bleeding (CRNMB) events | CRNMB events by International Society on Thrombosis and Haemostasis (ISTH) criteria2 and composite major bleeding and CRNMB events. | 3 months and 6 months |
| Arterial thromboembolic events | Arterial thromboembolic events (objectively confirmed), including myocardial infarction, stroke, peripheral arterial disease, or other systemic arterial embolism. | 3 months and 6 months |
| All-cause mortality | All-cause mortality | 3 months and 6 months |
| Correlative biomarkers | Correlative biomarkers at 6 months, while the exact list of correlative biomarkers is to be determined at the time of study completion, examples include D-dimer, P-selectin, prothrombin F1+F2, thrombin generation, etc. | 6 months |
| Health-related quality of life using the EuroQoL-5D-5L Questionnaire | Health-related quality of life using EuroQoL-5D-5L (5Dimension- mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5L- severity levels) questionnaires on enrollment and at 6 months. EQ-5D-5L index scores range from -0.59 to 1, where 1 is the best possible health state. | 6 months |
| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| D009369 | Neoplasms |
| D056824 | Upper Extremity Deep Vein Thrombosis |
| D055499 | Catheter-Related Infections |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C522181 | apixaban |
Not provided
Not provided
Not provided