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Home > Studies > Trial to Reduce Alloimmunization to Platelets (TRAP)

Trial to Reduce Alloimmunization to Platelets (TRAP)

Accession Number
HLB00700909a

Study Type
Clinical Trial

Collection Type
Open BioLINCC Study See bottom of this webpage for request information

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

Study Population

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

 

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

 
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

 
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

 

Available Biospecimens

Please note that biospecimen availability is subject to review by the NHLBI, BioLINCC, and the NHLBI Biorepository. Certain biospecimens may not be made available for your request. Section 3 of the BioLINCC handbook describes the components of the review process

Visits (Vials):

10/26/2018

  Serum Total
Baseline 3,233 3,233
Week 1 2,077 2,077
Week 2 1,912 1,912
Week 3 1,989 1,989
Week 4 1,576 1,576
Week 5 1,693 1,693
Week 6 1,592 1,592
Week 7 1,518 1,518
Week 8 1,610 1,610
Month 3 1,532 1,532
Month 4 1,323 1,323
Month 5 1,122 1,122
Month 6 885 885
Month 7 859 859
Month 8 828 828
Month 9 703 703
Month 10 660 660
Month 11 579 579
Month 12 571 571
Death 9 9
Unknown 2,640 2,640

 

Visits (Subjects):

10/26/2018

  Serum
Total number of subjects Average volume (ml) per subject
Baseline 571 5.45
Week 1 549 4.96
Week 2 545 4.52
Week 3 515 5.03
Week 4 475 4.28
Week 5 449 4.68
Week 6 422 4.73
Week 7 398 4.71
Week 8 446 4.37
Month 3 415 4.54
Month 4 359 4.55
Month 5 322 4.30
Month 6 283 3.80
Month 7 258 4.18
Month 8 246 4.30
Month 9 208 4.12
Month 10 196 4.23
Month 11 179 4.06
Month 12 184 3.92
Death 3 3.00
Unknown 436 6.72

 


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Resources Available

Specimens and Study Datasets

Study Catalog

Study Publications (5)

Materials Available

  • Serum
  • More Details

Study Documents

  • PDF Data Dictionary (PDF - 299.3 KB)
  • PDF Protocol (PDF - 1.8 MB)
  • Forms

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