Optimal Platelet Dose Strategy for Management of Thrombocytopenia
Condition: Thrombocytopenia
MeSH terms: Thrombocytopenia
Intervention: Medium Dose Prophylactic Platelet Transfusions; Lower Dose Prophylactic Platelet Transfusions; Higher Dose Prophylactic Platelet Transfusions
Intervention description: 2.2 x 10^11 platelets per m^2 BSA; 1.1 x 10^11 platelets per m^2 BSA; 4.4 * 10^11 platelets per m^2 BSA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1351.0
Sex: All
Maximum age: 100 Years
Healthy volunteers: No
Keywords: Blood Transfusion; Blood Platelets

Summary:

      The primary objective of this study is to compare the three study arms of lower, medium, and
      higher dose platelet therapy with respect to the percentage of patients experiencing at least
      one episode of Grade 2 or higher bleeding as determined by the Platelet Dose Trial Bleeding
      Scale (Grade 2 bleeding corresponds to bleeding that is moderate, but not severe enough to
      warrant red blood cell transfusion).

      There are a number of secondary endpoints related to platelet transfusions, hemostasis, and
      other concerns. The four most important secondary endpoints will compare the three study arms
      with respect to the following outcomes: 1) platelet utilization rates (total number of
      platelets transfused x 10 ^11); 2) number of platelet transfusion events (frequency of
      transfusions); a transfusion event would be defined as each separate platelet transfusion
      issued by the study site's transfusion service; 3) highest category of bleeding during time
      of study (Platelet Dose Trial Bleeding Scale Grades less than or equal to 1, 2, 3, or 4 by
      arm); and 4) bleeding severity based on number of days with bleeding (total days of bleeding
      and bleeding/thrombocytopenic day), intensity of bleeding, and number of sites with bleeding
      (if such a severity score has been validated and published by the time the study is
      completed).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has, or is expected to have, hypoproliferative thrombocytopenia, and is expected to
             have a platelet count of up to 10,000 ul for at least 5 days and be in the hospital
             for at least 5 days

          -  Weight is between 10 and 135 kilograms

          -  PT/INR, PTT, and fibrinogen assays that are measured within 72 hours before study
             entry are as follows:

               1. PT less than or equal to 1.3 times the upper limit of normal for the laboratory

               2. PTT less than or equal to 1.3 times the upper limit of normal for the laboratory

               3. Fibrinogen greater than or equal to 100 mg/dl

          -  Undergoing, or has completed, hematopoietic stem cell transplantation, for any
             diagnosis; OR has a diagnosis of acute or chronic leukemia, non-Hodgkins or Hodgkins
             lymphoma, myeloma, myelodysplasia, or non-hematologic malignancy and is undergoing, or
             has completed, chemotherapy

          -  During this hospitalization, the patient has not yet received any platelet
             transfusions related to the current or planned course of therapy (individual platelet
             transfusions given prior to the study and unrelated to thrombocytopenia will not
             exclude the patient)

        Exclusion Criteria:

          -  Evidence of greater than or equal to Grade 2 bleeding (as determined by the Platelet
             Dose Trial Bleeding Scale)

          -  Receiving antithrombotic drugs

          -  Will receive bedside leuko-reduced platelet transfusions

          -  Present, or history of, platelet transfusion refractoriness within 30 days prior to
             study entry

          -  Pre-enrollment lymphocytotoxic antibody screen (PRA) known to be greater than or equal
             to 20% based on prior data

          -  Present, or history of, acute promyelocytic leukemia (APML), immune thrombocytopenic
             purpura (ITP), thrombotic thrombocytopenic purpura (TTP), or hemolytic-uremic syndrome
             (HUS)

          -  Will be transfused at platelet trigger of greater than 10,000 platelets/ul

          -  Recent history of major surgery (within 2 weeks of study entry)

          -  Currently taking, or participating in a study involving, platelet substitutes,
             platelet growth factors, or pharmacologic agents intended to enhance or decrease
             platelet hemostatic function

          -  Pregnant

          -  Previously enrolled in this study