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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
4
Undergo lower dose platelet transfusion
Undergo higher dose platelet transfusion
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Number of Eligible Patients Approached for the Study
Time frame: Up to 1 year
Number of Patients Approached for But Refusing Consent
Reasons for ineligibility will be reported qualitatively in order to inform future studies.
Time frame: Up to 1 year
Number of Patients Consenting to Enrollment
Time frame: Up to 1 year
Number of Patients Eligible
Time frame: Up to 1 year
Number of Patients Screened and Deemed Ineligible
Reasons for ineligibility will be reported qualitatively in order to inform future studies.
Time frame: Up to 1 year
Number of Patients Successfully Following Protocol
Will evaluate the number of patients successfully following protocol, defined as receiving transfusions 'on protocol' at the end of the study period.
Time frame: Up to 1 year
Incidence of Hemorrhagic Events (World Health Organization Grade 2 or Greater)
Will evaluate the incidence of hemorrhagic events (World Health Organization grade 2 or greater).
Time frame: Up to 1 year
Major Bleeds (World Health Organization Grade 3 or 4)
Will evaluate the major bleeds (World Health Organization grade 3 or 4).
Time frame: Up to 1 year
Number of Platelet Transfusions Per Patient During the Study Period
Time frame: Up to 1 year
Percent of Days on Which Subjects Are Transfused (or Transfusion Are Not Given)
The frequency with which transfusions are given despite a platelet count above the determined threshold will be documented, as will the frequency with which transfusions are not administered within 24 hours after a platelet count below the determined threshold.
Time frame: Up to 1 year
Platelet Transfusion Related Complications
Total number of transfusion reactions, patients experiencing alloimmunization and volume overload will be reported.
Time frame: Up to 1 year
Progressive or New Arterial Thromboembolism
Will evaluate the progression or new arterial thromboembolism by either documented acute electrocardiographic changes compatible with myocardial injury and/or serum biochemical changes diagnostic of myocardial infarction, or documented imaging (computed tomography or magnetic resonance imaging) changes compatible with infarct due to embolism in the presence of a new neurological deficit, or imaging demonstrated intraluminal filling defects in an arterial distribution accompanied by symptoms of acute ischemia (acute onset pain, pallor, loss of pulses or other end-organ damage).
Time frame: Up to 1 year
Progressive or New Venous Thromboembolic
Will evaluate the progressive or new venous thromboembolic. Will require imaging confirmation, defined as intraluminal filling defect(s) on contrast-enhanced computed tomography or incompressible venous segment(s) on ultrasonography.
Time frame: Up to 1 year
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