Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000589
Status:
COMPLETED
Last Update Posted:
2016-11-06
First Post:
1999-10-27
Brief Title:
Trial to Reduce Alloimmunization to Platelets TRAP
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
BACKGROUND
Between 1971 and 1980 there was a 598 percent increase in the use of platelet concentrates from 041 million to more than 286 million annually In contrast red cell transfusions in the United States rose concurrently from 63 million annually to 99 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 APCs 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
Between 1971 and 1980 there was a 598 percent increase in the use of platelet concentrates from 041 million to more than 286 million annually In contrast red cell transfusions in the United States rose concurrently from 63 million annually to 99 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 APCs 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01HL042824 | NIH | None | httpsreporternihgovquickSearchU01HL042824 |