Status:
COMPLETED
Optimal Platelet Dose Strategy for Management of Thrombocytopenia
Lead Sponsor:
Carelon Research
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Transfusion Medicine/Hemostasis Clinical Research Network
Conditions:
Thrombocytopenia
Eligibility:
All Genders
Up to 100 years
Phase:
PHASE3
Brief 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 o...
Detailed Description
BACKGROUND: It is important to identify the safest and most cost effective strategies for providing platelet support that will achieve effective disease management without depleting platelet supplies...
Eligibility Criteria
Inclusion
- 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:
- PT less than or equal to 1.3 times the upper limit of normal for the laboratory
- PTT less than or equal to 1.3 times the upper limit of normal for the laboratory
- 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
- 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
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
1351 Patients enrolled
Trial Details
Trial ID
NCT00128713
Start Date
July 1 2004
End Date
January 1 2008
Last Update
October 28 2015
Active Locations (21)
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1
Emory University Hospitals; Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
2
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
3
Tulane University Hospital and Clinics
New Orleans, Louisiana, United States, 70112
4
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201