Trial to Reduce Alloimmunization to Platelets (TRAP)
Accession Number
HLB00700909a
Study Type
Clinical Trial
Collection Type
Open BioLINCC Study
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Study Period
1989-1997
NHLBI Division
DBDR
Date Prepared
January 29, 2009
Last Updated
June 23, 2005
Clinical Trial URLs
https://clinicaltrials.gov/ct2/s...
Primary Publication URLs
https://www.ncbi.nlm.nih.gov/pub...
Study Website
N/A
Consent
Commercial Use Data Restrictions No
Data Restrictions Based On Area Of Research No
Commercial Use Specimen Restrictions No
Non-Genetic Use Specimen Restrictions Based On Area Of Use No
Genetic Use Of Specimens Allowed? Yes
Genetic Use Area Of Research Restrictions No
Specific Consent Restrictions
None.
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.
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.
Subjects
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.
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.
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)
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.
Additional Details
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
|
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 |
|
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 |
|
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 |
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