Protocols

Determination of the Optimal Prophylactic Platelet Dose to Prevent Bleeding in Thrombocytopenic Patients (PLADO)
The PLADO study was a randomized trial comparing three doses (lower dose, medium dose, and higher dose) for prophylactic platelet transfusions in patients with thrombocytopenia due to stem cell transplant or chemotherapy. The primary outcome was the percentage of patients who had at least one day of Grade 2 or higher bleeding according to the WHO scale. Key secondary outcomes included highest grade of bleeding, total number of platelets transfused, and number of transfusion events. The trial was completed in January 2008 with 1351 subjects enrolled. There were no significant differences between treatment arms in the primary endpoint. The primary manuscript was published in The New England Journal of Medicine; 2010 February 18; 362(7):600-613.

Rituximab for the Treatment of Inhibitors in Congenital Hemophilia A (RICH)
The RICH study was a single-arm, Phase II study of rituximab treatment for patients with congenital hemophilia A and high-titer inhibitors to Factor VIII. Eligible subjects with a history of high-titer inhibitors received a challenge dose of Factor VIII. Those whose post-challenge inhibitor titer was at least 5 Bethesda Units were eligible for the treatment phase of the study, which consisted of rituximab infusions given weekly for four weeks. The primary endpoint was the percentage of subjects who had a post-treatment inhibitor titer of < 5 Bethesda Units, and remained at < 5 Bethesda Units after another challenge with Factor VIII. The Study was closed to new enrollment as of November, 2010. Twenty-three subjects were enrolled.

Resolving Infection in Neutropenia with Granulocytes (RING)
The RING study is a randomized trial enrolling patients who are neutropenic due to marrow failure caused by underlying disease or therapy, and have a proven, probable or presumptive infection. One group of patients will be treated with antimicrobial therapy alone, and the other group will be treated with antimicrobial therapy plus GCSF-stimulated granulocyte transfusions. The primary outcome is the percentage of patients who are alive at 42 days after study entry, and have had their infection resolve or improve. The target enrollment is 236. The study began enrollment in April 2008 and is ongoing.

Initial Treatment of Patients with Immune Thrombocytopenic Purpura (ITP2)
The ITP2 study is a randomized, double-blinded trial for patients presenting with a platelet count of ≤ 150,000/µL due to newly diagnosed Immune Thrombocytopenic Purpura (ITP). One group of patients will receive standard therapy with prednisone, and the other group will receive four-day courses of dexamethasone, repeated every 14 days for a total of three courses. The primary outcome is the percentage of patients in each treatment arm who remain free of all ITP therapy with a platelet count of ≥ 50,000/µL from 60 days through 365 days after study entry. The target enrollment is 140. The study began enrollment in January 2010 and is ongoing.

REd CEll Storage Duration Study (RECESS)
The "Red Cell Storage Duration Study" (RECESS) is a randomized, controlled, partially-blinded clinical trial for cardiac surgery patients who are likely to be transfused with allogeneic red blood cells (RBCs) during or after complex cardiac surgery. One group of patients will receive RBCs stored ≤ 10 days at the time of transfusion, and the other group will receive RBCs stored ≥ 21 days at the time of transfusion. The primary outcome is the change in clinical outcome assessed using the Multiple Organ Dysfunction Score (MODS), which is a composite endpoint of multi-system organ dysfunction including death. The target sample size is 1648 subjects. The study began enrollment in June 2010 and is ongoing.

Heparin-Induced Thrombocytopenia - Retrospective Analysis of Data on Incidence and Outcomes Study (HIT-RADIO Study)
The HIT-RADIO study was a retrospective chart review study for patients found to have a positive heparin PF-4 antibody test between 1/21/2008 and 9/25/2008. The primary outcome was the rate of the triple endpoint of death, limb amputation/gangrene, and new thrombosis after the time the positive heparin PF-4 antibody test was drawn. The study was completed in December 2010 and enrolled 673 subjects.

The "Mechanism and Repository Study (MARS) for the Red Cell Storage Duration Study (RECESS)"
MARS is an ancillary study of the RECESS study that will analyze the most commonly reported and hypothesized mechanisms considered to be associated with the RBC storage lesion and possible adverse outcomes in critically ill patients. The study will also develop a large sample repository for future analysis. Enrollment for the study is expected to begin in September 2011.

Click here to print this page

 © Transfusion Medicine/Hemostasis Network. All rights reserved