STrategies for Anticoagulation in Patients With thRombocytopenia and Cancer-associated Thrombosis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorTzu-Fei Wang
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Receipt of anticoagulant for index VTE with platelet count < 50,000/uL for > 72 hours;
Superficial vein thrombosis only;
Life expectancy < 1 month (as judged by the treating physicians);
Creatinine clearance < 30 ml/min;
Trial design
Design model
Parallel
Treatments tested in this trial
Enoxaparin
Biological/VaccineI. Platelet count 25-50,000/µL: 0.5mg/kg subcutaneously twice daily II. Platelet count \< 25,000/µL: hold anticoagulation
Dalteparin
Biological/VaccineI. Platelet count 25-50,000/µL: 100 IU/kg subcutaneously daily for the first month of an acute VTE then 75 U/kg II. Platelet count \< 25,000/µL: hold anticoagulation
Tinzaparin
Biological/VaccineI. Platelet count 25-50,000/µL: 87.5 units/kg subcutaneously daily II. Platelet count \< 25,000/µL: hold anticoagulation
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Modified dose LMWH without platelet transfusion supportExperimental treatment 3 interventions
Group B: Higher dose LMWH with platelet transfusion supportActive comparator 3 interventions
Trial outcomes
Primary outcomes
1
Feasibility - The average number of patients recruited per month
The average number of patients recruited per month
Time frame
18 monthsSecondary outcomes
1
Feasibility - Proportion of eligible patients who provide consent
Number of consenting participants from the number of eligible patients
Time frame
18 months2
Feasibility - Reasons for non-participation in eligible patients
Reasons for non-participation in eligible patients
Time frame
18 months3
Feasibility - Number of patients who complete study procedures by adhering to protocol
Number of participants adhering to the protocol (such as anticoagulation, transfusion, platelet count monitoring according to the protocol)
Time frame
18 months4
Feasibility - Rates of withdrawal
Number of participants withdrawing from study
Time frame
18 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Tzu-Fei Wang
Lead sponsor
Ottawa Hospital Research Institute
Sponsor institution
Source ClinicalTrials.gov