Optimal Platelet Dose Strategy for Management of Thrombocytopenia

Completed · Phase 3

Conditions studied: Thrombocytopenia

In brief

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).

Key facts

Study ID

NCT00128713

Run by

Carelon Research

People needed

1351

Starts

2004-07-01

Expected to finish

2008-01-01

Last updated by the study team

2015-10-28

Who can join

Age: any, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Emory University Hospitals; Children's Healthcare of Atlanta — Atlanta, Georgia, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• Tulane University Hospital and Clinics — New Orleans, Louisiana, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Children's Hospital Boston; Beth Israel Deaconess Medical Center; Brigham and Women's Hospital — Boston, Massachusetts, United States
• University of Minnesota Medical Center, Fairview — Minneapolis, Minnesota, United States
• NY-Presbyterian Hosp/Weill Cornell Medical Center — New York, New York, United States
• University of North Carolina Hospitals — Chapel Hill, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• University Hospital Cleveland — Cleveland, Ohio, United States
• U of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
• U of Pennsylvania Health System; Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• University of Pittsburgh Presbyterian and Shadyside Hospital — Pittsburgh, Pennsylvania, United States
• U of Texas SW Medical Center at Dallas — Dallas, Texas, United States
• Virginia Mason Hospital — Seattle, Washington, United States
• U of Washington Medical Center/FHCRC; Children's Hospital and Medical Center — Seattle, Washington, United States
• University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States
• Children's Hospital of Wisconsin — Milwaukee, Wisconsin, United States
• Oncology Alliance/St. Luke's Hospital — Milwaukee, Wisconsin, United States
• Froedtert Memorial Lutheran Hospital — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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