RecruitingPhase 4NCT05255003

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

Sponsor

Tzu-Fei Wang

Enrollment

50 participants

Start Date

Aug 29, 2022

Study Type

INTERVENTIONAL

Conditions

Thrombocytopenia Cancer-associated Thrombosis

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

Min Age: 18 Years

Inclusion Criteria4

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

Exclusion Criteria9

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;
Contraindication to LMWH such as a history of heparin induced thrombocytopenia;
Thrombocytopenia from other causes, such as thrombotic microangiopathy, immune thrombocytopenia, disseminated intravascular coagulation;
Previously documented history of refractoriness to platelet transfusion secondary to HLA antibodies;
Refusal of blood products;
Anticoagulation at any dose is deemed unsafe (i.e. active bleeding or bleeding disorders)

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Interventions

BIOLOGICALEnoxaparin

I. Platelet count 25-50,000/µL: 0.5mg/kg subcutaneously twice daily II. Platelet count \< 25,000/µL: hold anticoagulation

BIOLOGICALDalteparin

I. 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

BIOLOGICALTinzaparin

I. Platelet count 25-50,000/µL: 87.5 units/kg subcutaneously daily II. Platelet count \< 25,000/µL: hold anticoagulation