Optimal Platelet Dose Strategy for Management of Thrombocytopenia

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).

Conditions

• Thrombocytopenia

Interventions

PROCEDURE

Medium Dose Prophylactic Platelet Transfusions

2.2 x 10\^11 platelets per m\^2 BSA

PROCEDURE

Lower Dose Prophylactic Platelet Transfusions

1.1 x 10\^11 platelets per m\^2 BSA

PROCEDURE

Higher Dose Prophylactic Platelet Transfusions

4.4 \* 10\^11 platelets per m\^2 BSA

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Transfusion Medicine/Hemostasis Clinical Research Network

  collaborator NETWORK

• Carelon Research

  lead OTHER

Principal Investigators

• Susan F. Assmann · New England Research Institutes, Inc.

• Mark Brecher, MD · University of North Carolina

• James B. Bussel, MD · NY-Presbyterian Hosp/Weill Cornell Medical Center

• James George, MD · U of Oklahoma Health Sciences Center

• John R. Hess · University of Maryland, Baltimore

• Christopher D. Hillyer, MD · Emory University

• Barbara A. Konkle, MD · University of Pennsylvania

• Cindy A. Leissinger, MD · Tulane University

• Keith R. McCrae, MD · University Hospitals Cleveland

• Jeffrey McCullough, MD · University of Minnesota

• Janice G. McFarland, MD · Versiti

• Paul M. Ness, MD · Johns Hopkins University

• Ellis Neufeld, MD, PhD · Boston Children's Hospital

• Thomas L. Ortel, MD, PhD · Duke University

• Sherrill J. Slichter, MD · Bloodworks

• Ronald G. Strauss, MD · University of Iowa

• Darrell J. Triulzi, MD · University of Pittsburgh Presbyterian and Shadyside Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2004-07-31

Primary Completion

2008-01-31

Completion

2008-01-31

Countries

• United States

Study Locations