Clinical Trials Logo

Clinical Trial Summary

To determine the best, clinically useful procedure to prevent or minimize platelet alloimmunization as a cause of refractoriness to platelet transfusion in patients undergoing marrow ablative chemotherapy for acute myelogenous leukemia.


Clinical Trial Description

BACKGROUND:

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.

DESIGN NARRATIVE:

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 Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT00000589
Study type Interventional
Source National Heart, Lung, and Blood Institute (NHLBI)
Contact
Status Completed
Phase Phase 3
Start date August 1989
Completion date July 1997

See also
  Status Clinical Trial Phase
Recruiting NCT04094844 - Health Information Technology System ("Roadmap 2.0") in the Context of Hematopoietic Cell Transplantation N/A
Completed NCT04474678 - Quality Improvement Project - "My Logbook! - I Know my Way Around!"; ("Mein Logbuch - Ich Kenne Mich Aus!") N/A
Recruiting NCT03918343 - Lipopolysaccharide Metabolism and Identification of Potential Biomarkers Predictive of Graft-versus-host Disease After Allogeneic Stem Cell Transplantation N/A
Completed NCT01445561 - Ultra Low Dose Interleukin-2 in Healthy Volunteers Phase 1
Recruiting NCT06148610 - Evaluation of the Impact of the Use of NewSpringForMe on Transplanted Patients' Quality of Life and Support
Completed NCT04168983 - Impact of Sophrology on the Pain Felt During a Bone Marrow Aspiration and Biopsy N/A
Not yet recruiting NCT05969821 - Clonal Hematopoiesis of Immunological Significance
Withdrawn NCT04282174 - CD34+ Enriched Transplants From HLA-Compatible Patients With Hematologic Malignancies Phase 2
Completed NCT01108159 - Integrated Whole-Genome Analysis of Hematologic Disorders
Completed NCT00800839 - Busulfan and Fludarabine Followed by Post-transplant Cyclophosphamide Phase 2
Completed NCT00213239 - A Dose Finding Study of Remifentanil and Propofol for Lumbar Punctures in Children Phase 1/Phase 2
Terminated NCT00208949 - A Comparison of Dendritic Cell Content and T-Cell Phenotype Between Granulocyte Colony-Stimulating Factor (G-CSF) or G-CSF + Granulocyte Macrophage (GM)-CSF Phase 2
Terminated NCT00176826 - T-Cell Depletion and Stem Cell Transplant for Immune Deficiencies and Histiocytic Disorders Phase 2/Phase 3
Completed NCT00208962 - Allogeneic Cell Therapy for Adults With Hematologic Malignancies Phase 2
Completed NCT00000603 - Cord Blood Stem Cell Transplantation Study (COBLT) Phase 2
Completed NCT00000587 - Erythropoietin for Anemia Due to Zidovudine in Human Immunodeficiency Virus Infection Phase 2
Active, not recruiting NCT03655678 - A Safety and Efficacy Study Evaluating CTX001 in Subjects With Transfusion-Dependent β-Thalassemia Phase 2/Phase 3
Recruiting NCT05487794 - Effect of Dose Fractionation of Testosterone Cypionate on Transgender Men With Erythrocytosis N/A
Completed NCT03611257 - Effect of dRAST on Treatment for Bacteremia in Patients With Hematologic Diseases N/A
Completed NCT02827149 - High Resolution Donor Recipient HLA Matching Level in Unrelated HSCT