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

Who is this study for? Patients with Cancer-associated Thrombosis, Thrombocytopenia
What treatments are being studied? Enoxaparin+Dalteparin+Tinzaparin
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 4
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 4 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 90 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 in these patients.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adult patients (age ≥ 18) with active malignancy (malignancy diagnosed or treated within the previous 6 months, or progressive/relapsed);

• Objectively confirmed VTE within last 14 days for which therapeutic anticoagulation is planned;

• Thrombocytopenia with a platelet count \< 50,000/uL from cancer therapy or malignancy itself;

• Able to provide written informed consent

Locations
Other Locations
Canada
University of Alberta
NOT_YET_RECRUITING
Edmonton
The Ottawa Hospital
RECRUITING
Ottawa
Windsor Regional Hospital
RECRUITING
Windsor
Contact Information
Primary
Jennifer Brinkhurst
jbrinkhurst@ohri.ca
+16137378899
Time Frame
Start Date: 2022-08-29
Estimated Completion Date: 2025-03-31
Participants
Target number of participants: 50
Treatments
Experimental: Modified dose LMWH without platelet transfusion support
Patients will be given modified dose LMWH as below based on the first platelet count of the day (daily in admitted patients or at least 2 times a week in outpatients), without empiric platelet transfusion:~I. Platelet count 25-50,000/µL: 50% dose LMWH~II. Platelet count \< 25,000/µL: hold anticoagulation
Active_comparator: Higher dose LMWH with platelet transfusion support
Patients assigned to higher dose LMWH (see below) will be given transfusion for 14 days when the first platelet count of the day falls below 50,000/uL (daily inpatient or at least 2 times a week in outpatients). Post-transfusion counts will not be routinely obtained unless clinically indicated~I. Platelet count 25-50,000/µL: platelet transfusion + 100% dose LMWH~II. Platelet count \< 25,000/µL: platelet transfusion + 50% dose LMWH~After Day 14, patients will be transitioned to modified dose LMWH as the other arm without platelet transfusion.~LMWH can include enoxaparin, dalteparin, or tinzaparin, with 100% as:~* Enoxaparin - 1mg/kg subcutaneously twice daily~* Dalteparin - 200 IU/kg subcutaneously daily for 1 month then 150 U/kg daily~* Tinzaparin - 175 units/kg subcutaneously daily
Related Therapeutic Areas
Sponsors
Leads: Ottawa Hospital Research Institute

This content was sourced from clinicaltrials.gov