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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• The Ottawa Hospital
  Ottawa, Ontario, Canada Recruiting
• Niagara Health - St. Catharines Site
  Saint Catharines, Ontario, Canada Recruiting
• Windsor Regional Hospital
  Windsor, Ontario, Canada Recruiting
• University of Alberta
  Edmonton, Alberta, Canada Withdrawn

Study contacts

• Principal investigator: Tzu-Fei Wang, MD — Ottawa Hospital Research Institute
• Study coordinator: Jennifer Brinkhurst
• Email: jbrinkhurst@ohri.ca
• Phone: +16137378899

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.