NCT03195010

Management of Platelet Transfusion Therapy in Patients With Blood Cancer or Treatment-Induced Thrombocytopenia

Management of Venous Thromboembolic Events (VTE) in Patients With Hematologic Disorders and Treatment-Induced Thrombocytopenia: A Pilot Study

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot clinical trial compares the safety of two different platelet transfusion "thresholds" among patients with blood cancer or treatment-induced thrombocytopenia whose condition requires anticoagulant medication (blood thinners) for blood clots. Giving relatively fewer platelet transfusions may reduce the side effects of frequent platelet transfusions without leading to undue bleeding.

Detailed description

PRIMARY OBJECTIVES: I. To determine feasibility of a randomized controlled trial comparing two different platelet transfusion thresholds (50 x 10\^9/L versus \[vs\] 30 x 10\^9/L) in patients with treatment or malignancy-induced thrombocytopenia requiring therapeutic anticoagulation. SECONDARY OBJECTIVES: I. Progressive or new venous thromboembolic (VTE). II. Progressive or new arterial thromboembolism (ATE). III. Hemorrhagic events (World Health Organization \[WHO\] grade 2 or greater). IV. A composite of I, II and III. V. Major bleeds (WHO grade 3 or 4). VI. Number of platelet transfusions per patient during the study period. VII. Platelet transfusion related complications (including transfusion reactions, alloimmunization and volume overload). VIII. Degree to which platelet target thresholds are achieved. OUTLINE: Patients are randomized into 1 of 2 groups. GROUP I (Lower dose): Patients undergo platelet transfusion on all days when the morning platelet count is below the threshold 30 x 10\^9/L for up to 30 days or until the platelet count spontaneously recovers to \> 50 x 10\^9 for 3 consecutive days in the absence of transfusions. GROUP II (Higher dose): Patients undergo platelet transfusion on all days when the morning platelet count is below the threshold 50 x 10\^9/L for up to 30 days or until the platelet count spontaneously recovers to \> 50 x 10\^9 for 3 consecutive days in the absence of transfusions. After completion of study, patients are followed up at 30 days.

Conditions

• Acute Biphenotypic Leukemia
• Acute Lymphoblastic Leukemia
• Acute Myeloid Leukemia
• B-Cell Non-Hodgkin Lymphoma
• Chronic Lymphocytic Leukemia
• Chronic Myelogenous Leukemia, BCR-ABL1 Positive
• Hematologic and Lymphocytic Disorder
• Hematopoietic Cell Transplantation Recipient
• Myelodysplastic Syndrome
• Primary Myelofibrosis
• Secondary Myelofibrosis
• T-Cell Non-Hodgkin Lymphoma
• Thrombocytopenia
• Venous Thromboembolism

Interventions

Type	Name	Description
BIOLOGICAL	Platelet Transfusion	Undergo lower dose platelet transfusion
BIOLOGICAL	Platelet Transfusion	Undergo higher dose platelet transfusion

Timeline

• Start date: 2017-06-09
• Primary completion: 2018-12-21
• Completion: 2018-12-21
• First posted: 2017-06-22
• Last updated: 2019-10-21
• Results posted: 2019-10-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study