Strategies for anticoagulation in cancer patients with low platelet counts and blood clots

STrategies for Anticoagulation in Patients With thRombocytopenia and Cancer-associated Thrombosis

This study is testing two different ways to treat blood clots in cancer patients with low platelet counts to see which method causes fewer bleeding problems.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ottawa Hospital Research Institute (other)
• Locations: 4 sites (Edmonton, Alberta and 3 other locations)
• Trial ID: NCT05255003 on ClinicalTrials.gov

What this trial studies

This pilot trial aims to assess the feasibility of a larger randomized controlled trial (RCT) focused on cancer patients who have developed blood clots and also have low platelet counts due to cancer or its treatment. The study will randomly assign 50 adult patients to receive either a full dose of low molecular weight heparin (LMWH) with platelet transfusions or a modified dose of LMWH without transfusions. The goal is to evaluate which treatment strategy results in fewer bleeding complications while effectively managing blood clots. If successful, the pilot data will inform the design of a full-scale trial, potentially streamlining future research efforts.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with active cancer, low platelet counts, and a recent diagnosis of a blood clot.

Not a fit: Patients with thrombocytopenia from causes other than cancer or those with a life expectancy of less than one month may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to safer anticoagulation strategies for cancer patients with low platelet counts, reducing the risk of bleeding while effectively treating blood clots.

How similar studies have performed: While this approach is novel in its specific focus on cancer patients with thrombocytopenia, similar studies have shown promise in managing anticoagulation in patients with varying conditions.

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)

Where this trial is running

Edmonton, Alberta and 3 other locations

• University of Alberta — Edmonton, Alberta, Canada (WITHDRAWN)
• The Ottawa Hospital — Ottawa, Ontario, Canada (RECRUITING)
• Niagara Health - St. Catharines Site — Saint Catharines, Ontario, Canada (RECRUITING)
• Windsor Regional Hospital — Windsor, Ontario, Canada (RECRUITING)

Study contacts

• Principal investigator: Tzu-Fei Wang, MD — Ottawa Hospital Research Institute
• Study coordinator: Jennifer Brinkhurst

Conditions: Cancer-associated Thrombosis, Thrombocytopenia