Trial to Reduce Alloimmunization to Platelets (TRAP) - Catalog
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Name
Trial to Reduce Alloimmunization to Platelets (TRAP)
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Accession Number
HLB00700909a
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Acronym
TRAP
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Related studies
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BSI Study IDs
TRA (Not Included in Utilization Report)
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Is public use dataset
False
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Keywords
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Has Study Datasets
True
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Has Specimens
False
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Specimen ID TypeNot Applicable (Data Only)
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Study Website
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The Framingham Heart Study Group requires that the requestor must obtain full or expedited IRB/Ethics Committee review and approval to obtain these data. Waivers or a determination that the research is exempt from ethical regulations do not suffice.
False
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Clinical Trial URLs
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Study typeClinical Trial
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Collection TypeOpen BioLINCC Study
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Cohort typeBoth
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Interventions
Procedure: platelet transfusion
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Study Open Date (Data)
2009-10-01
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Study Open Date (Specimens)
2010-05-14
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Date materials available
2009-01-29
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Last updated
2005-06-23
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Study period
1989-1997
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Study Contacts
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NHLBI Division
DBDR
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ClassificationTransfusion Medicine
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HIV study classificationnon-HIV
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COVID study classificationnon-COVID
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Pre-Website # of Specimens Shipped
25
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# of Returned Specimens
0
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Primary Publication URLs
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Commercial use data restrictionsNo
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Data restrictions based on area of researchNo
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Commercial use specimen restrictionsNot Applicable (Data Only)
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Non-genetic use specimen restrictions based on area of useNot Applicable (Data Only)
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Genetic use of specimens allowed?Not Applicable (Data Only)
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Genetic use area of research restrictionsNot Applicable (No Genetic Use Specimens)
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Specific Consent Restrictions
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ConditionsBlood Platelets
Blood Transfusion
Hematologic Diseases
Immunization
Leukemia, Myelocytic, Acute
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Objectives
To conduct a multi-institutional, randomized, blinded trial to determine whether the use of platelets from which leukocytes had been removed by a filter or that had been treated with ultraviolet B irradiation would prevent the formation of antiplatelet alloantibodies and refractoriness to platelet transfusions.
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Background
A 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.
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Participants
1047 male and female thrombocytopenic patients, ages 15 and over, newly diagnosed with acute myelogenous leukemia (AML) and undergoing chemotherapy were screened with 603 of them being enrolled between January 14, 1991, and February 28, 1995. Patients were excluded because of no or low-dose chemotherapy, a prior hematopoietic disorder treated with transfusions, prior chemotherapy, logistic reasons, prior treatment for leukemia, refusal to enter the study, or administration of corticosteroids.
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Design
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 (F-PC), ultraviolet irradiated pooled random donor platelets (UVB-PC), or leukocyte-poor filtered single donor apheresis platelets (F-AP). Patients in the control group received routinely pooled, random-donor platelets. All patients received transfusions of filtered, leukocyte-reduced red cells. 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.
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Conclusions
Reduction of leukocytes by filtration and ultraviolet B irradiation of platelets are equally effective in preventing alloantibody-mediated refractoriness to platelets during chemotherapy for acute myeloid leukemia. Platelets obtained by apheresis from single random donors provided no additional benefit as compared with pooled platelet concentrates from random donors (NEJM 1997;337:1861-1870)
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Disease classification
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Publications
Slichter SJ, Davis K, Enright H, Braine H, Gernsheimer T, Kao KJ, Kickler T, Lee E, McFarland J, McCullough J, Rodey G, Schiffer CA, Woodson R. Factors affecting posttransfusion platelet increments, platelet refractoriness, and platelet transfusion intervals in thrombocytopenic patients. Blood. 2005; 105(10):4106-14.
Enright H, Davis K, Gernsheimer T, McCullough JJ, Woodson R, Slichter SJ. Factors influencing moderate to severe reactions to PLT transfusions: experience of the TRAP multicenter clinical trial. Transfusion. 2003; 43(11):1545-52.
Davis KB, Slichter SJ, Corash L. Corrected count increment and percent platelet recovery as measures of posttransfusion platelet response: problems and a solution. Transfusion. 1999; 39(6):586-92.
Leukocyte reduction and ultraviolet B irradiation of platelets to prevent alloimmunization and refractoriness to platelet transfusions. The Trial to Reduce Alloimmunization to Platelets Study Group. N Engl J Med. 1997; 337(26):1861-9.
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Mat types
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Network
The study population available in BioLINCC study data may be lower than total study enrollment due to Informed Consent restrictions and other factors.
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Subjects
Pooled random donor: 148
UV-B irradiated pooled random donor: 152
Leuko-poor pooled random donor:152
Leukocyte-poor filtered apheresis non-HLA selected single donor platelets: 151
Last Modified: July 28, 2014, 4:37 p.m. -
Age
Pooled
random
donor
UV-B irradiated
pooled random
donor
Leuko-poor
pooled random
donor
Leukocyte-poor
filtered apheresis
non-HLA-selected
single donor platelets
All
N
%
N
%
N
%
N
%
N
%
16-20
5
3.38
4
2.63
8
5.26
6
3.97
23
3.81
21-25
5
3.38
5
3.29
5
3.29
6
3.97
21
3.48
26-30
11
7.43
8
5.26
5
3.29
10
6.62
34
5.64
31-35
9
6.08
12
7.89
10
6.58
7
4.64
38
6.30
36-40
18
12.16
7
4.61
10
6.58
12
7.95
47
7.79
41-45
13
8.78
6
3.95
9
5.92
11
7.28
39
6.47
46-50
18
12.16
9
5.92
10
6.58
10
6.62
47
7.79
51-55
10
6.76
17
11.18
14
9.21
16
10.60
57
9.45
56-60
8
5.41
14
9.21
15
9.87
12
7.95
49
8.13
61-65
20
13.51
19
12.50
22
14.47
16
10.60
77
12.77
66-70
13
8.78
22
14.47
27
17.76
16
10.60
78
12.94
71-75
15
10.14
20
13.16
10
6.58
21
13.91
66
10.95
76-80
3
2.03
6
3.95
7
4.61
6
3.97
22
3.65
81-85
.
.
3
1.97
.
.
.
.
3
0.50
86-90
.
.
.
.
.
.
2
1.32
2
0.33
Last Modified: March 11, 2016, 2:48 p.m. -
Sex
Pooled
random
donor
UV-B irradiated
pooled random
donor
Leuko-poor
pooled random
donor
Leukocyte-poor
filtered apheresis
non-HLA-selected
single donor platelets
All
N
%
N
%
N
%
N
%
N
%
Female
72
48.65
84
55.26
80
52.63
74
49.01
310
51.41
Male
76
51.35
68
44.74
72
47.37
77
50.99
293
48.59
Last Modified: March 11, 2016, 2:48 p.m. -
Race
Pooled
random
donor
UV-B irradiated
pooled random
donor
Leuko-poor
pooled random
donor
Leukocyte-poor
filtered apheresis
non-HLA-selected
single donor platelets
All
N
%
N
%
N
%
N
%
N
%
White
127
85.81
136
89.47
135
88.82
134
88.74
532
88.23
Black
15
10.14
12
7.89
12
7.89
10
6.62
49
8.13
Other
6
4.05
4
2.63
5
3.29
7
4.64
22
3.65
Last Modified: March 11, 2016, 2:48 p.m.