Acute Myeloid Leukemia Clinical Trial
Official title:
Management of Venous Thromboembolic Events (VTE) in Patients With Hematologic Disorders and Treatment-Induced Thrombocytopenia: A Pilot Study
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.
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.
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