NCT05255003 STrategies for Anticoagulation in Patients With thRombocytopenia and Cancer-associated Thrombosis
| NCT ID | NCT05255003 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Tzu-Fei Wang |
| Condition | Cancer-associated Thrombosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2022-08-29 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 50 participants in total. It began in 2022-08-29 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Patients with cancer are prone to have blood clots, which are usually treated with blood thinners. The main complication of blood thinners is bleeding. This is especially a concern when the number of platelets in the blood is lower than 50,000 per microliter. The role of platelets is to stop bleeding, so when the number of platelets is low, patients are at a higher risk of bleeding. Cancer patients are prone to have lower platelet numbers due to cancer therapies and/or cancer itself. It is not clear what the best treatment is for cancer patients who need blood thinners for a blood clot but have low platelet counts. The investigators plan to do a small study called a pilot study to help plan for a larger study in such patients. In the pilot study, investigators will include 50 patients with cancer, low platelet counts, and a blood clot diagnosed within 2 weeks. Patients will be randomly assigned to one of the two treatment strategies: the full dose of blood thinners along with platelet transfusion or a reduced dose of blood thinners without platelet transfusion. The investigators will follow all patients for 30 days. If this pilot study is successful, it will help lead to a much larger trial, which will provide important information on the best treatment strategy for these patients.
Eligibility Criteria
Inclusion Criteria: 1. Adult patients (age ≥ 18) with active malignancy (malignancy diagnosed or treated within the previous 6 months, or progressive/relapsed); 2. Objectively confirmed VTE within last 14 days for which therapeutic anticoagulation is planned; 3. Thrombocytopenia with a platelet count \< 50,000/uL from cancer therapy or malignancy itself; 4. Able to provide written informed consent Exclusion Criteria: 1. Receipt of anticoagulant for index VTE with platelet count \< 50,000/uL for \> 72 hours; 2. Superficial vein thrombosis only; 3. Life expectancy \< 1 month (as judged by the treating physicians); 4. Creatinine clearance \< 30 ml/min; 5. Contraindication to LMWH such as a history of heparin induced thrombocytopenia; 6. Thrombocytopenia from other causes, such as thrombotic microangiopathy, immune thrombocytopenia, disseminated intravascular coagulation; 7. Previously documented history of refractoriness to platelet transfusion secondary to HLA antibodies; 8. Refusal of blood products; 9. Anticoagulation at any dose is deemed unsafe (i.e. active bleeding or bleeding disorders)
Contact & Investigator
Tzu-Fei Wang, MD
PRINCIPAL INVESTIGATOR
Ottawa Hospital Research Institute
Frequently Asked Questions
Who can join the NCT05255003 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cancer-associated Thrombosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05255003 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05255003 currently recruiting?
Yes, NCT05255003 is actively recruiting participants. Contact the research team at jbrinkhurst@ohri.ca for enrollment information.
Where is the NCT05255003 trial being conducted?
This trial is being conducted at Edmonton, Canada, Ottawa, Canada, Saint Catharines, Canada, Windsor, Canada.
Who is sponsoring the NCT05255003 clinical trial?
NCT05255003 is sponsored by Tzu-Fei Wang. The principal investigator is Tzu-Fei Wang, MD at Ottawa Hospital Research Institute. The trial plans to enroll 50 participants.
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