Trial to Reduce Alloimmunization to Platelets (TRAP)
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|ClinicalTrials.gov Identifier: NCT00000589|
Recruitment Status : Completed
First Posted : October 28, 1999
Last Update Posted : November 6, 2016
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|Condition or disease||Intervention/treatment||Phase|
|Blood Platelets Hematologic Diseases Immunization Leukemia, Myelocytic, Acute Blood Transfusion||Procedure: platelet transfusion||Phase 3|
Between 1971 and 1980, there was a 598 percent increase in the use of platelet concentrates from 0.41 million to more than 2.86 million annually. In contrast, red cell transfusions in the United States rose concurrently from 6.3 million annually to 9.9 million, an increase of 58 percent. Although red cell transfusions have leveled or even decreased slightly in the past several years, the use of platelets has continued to increase at a rate of at least 5 to 10 percent each year. This dramatic and continued increase in the use of platelet concentrates is largely the result of treating thrombocytopenic cancer patients. In addition, open heart surgery patients and others given massive transfusions also receive substantial platelet support. Nevertheless, it is the chronically transfused thrombocytopenic patient who frequently develops platelet alloimmunization and accounts for a large percentage of the increased demand for platelets. A recent survey in a large transfusion service indicated that 8 percent of the patients had received 35 percent of the random-donor pooled platelet concentrates. Although some alloimmunized patients can be supported by HLA-matched, apheresis-donor platelets, suitably matched donors are not available in sufficient numbers for every patient. Thus, platelet transfusion programs that could prevent, or at least delay platelet alloimmunization would be of substantial benefit.
Limited studies have suggested several approaches that may reduce or prevent platelet alloimmunization: reducing the number of foreign antigens to which a recipient is exposed by providing single donor platelet apheresis products; providing leukocyte-poor blood products; inactivating donor antigen presenting cells (APC's), a type of lymphocyte contained within the transfused platelet products, by ultraviolet (UV) irradiation of platelet concentrates.
The initiative was recommended by the Blood Diseases and Resources Advisory Committee in May 1987 and approved by the National Heart, Lung, and Blood Advisory Council in September 1987. The Requests for Applications were released in June 1988.
Randomized, double-blind. There were three treatment arms and one control arm. Patients in the treatment arms received either leukocyte-poor filtered pooled random donor platelets, or ultraviolet irradiated pooled random donor platelets, or leukocyte-poor filtered single donor apheresis platelets. Patients in the control group received routinely pooled, random-donor platelets. Patients remained on their assigned treatments for all transfusions through eight weeks. Assigned transfusions were discontinued only in the event of severe adverse reaction to the platelet transfusions, granulocyte transfusions, bone marrow transplant, withdrawal of informed consent, or death. Pre- and post transfusion counts were obtained for all platelet transfusions. Each patient was followed for one year. Recruitment continued through March 1995. Data analysis ended in July 1997.
The study completion date listed in this record was obtained from the "Completed Date" entered in the Protocol Registration and Results System.
|Study Type :||Interventional (Clinical Trial)|
|Study Start Date :||August 1989|
|Actual Study Completion Date :||July 1997|
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|Ages Eligible for Study:||15 Years to 75 Years (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000589
|OverallOfficial:||Hayden Braine||Johns Hopkins University|
|OverallOfficial:||Kuo-Jang Kao||University of Florida|
|OverallOfficial:||Jeffrey McCullough||University of Minnesota|
|OverallOfficial:||Janice McFarland||Blood Center of Southeastern Wisconsin|
|OverallOfficial:||Charles Schiffer||University of Maryland|
NHLBI provides controlled access to IPD through BioLINCC. Access requires registration, evidence of local IRB approval or certification of exemption from IRB review, and completion of a data use agreement.
|Other Study ID Numbers:||
U01HL042824 ( U.S. NIH Grant/Contract )
|First Posted:||October 28, 1999 Key Record Dates|
|Last Update Posted:||November 6, 2016|
|Last Verified:||May 2000|
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type