Trial to Reduce Alloimmunization to Platelets (TRAP) - Catalog

  • Name

    Trial to Reduce Alloimmunization to Platelets (TRAP)

  • Accession Number

    HLB00700909a

  • Acronym

    TRAP

  • Related studies
  • BSI Study IDs

    TRA (Not Included in Utilization Report)

  • Is public use dataset

    False

  • Keywords
  • Has Study Datasets

    True

  • Has Specimens

    False

  • Specimen ID Type
    Not Applicable (Data Only)
  • Study Website
  • 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

  • Clinical Trial URLs
  • Study type
    Clinical Trial
  • Collection Type
    Open BioLINCC Study
  • Cohort type
    Both
  • Interventions

    Procedure: platelet transfusion

  • Study Open Date (Data)

    2009-10-01

  • Study Open Date (Specimens)

    2010-05-14

  • Date materials available

    2009-01-29

  • Last updated

    2005-06-23

  • Study period

    1989-1997

  • Study Contacts
  • NHLBI Division

    DBDR

  • Classification
    Transfusion Medicine
  • HIV study classification
    non-HIV
  • COVID study classification
    non-COVID
  • Pre-Website # of Specimens Shipped

    25

  • # of Returned Specimens

    0

  • Primary Publication URLs
  • Conditions
    Blood Platelets
    Blood Transfusion
    Hematologic Diseases
    Immunization
    Leukemia, Myelocytic, Acute
  • 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.

  • 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.

  • 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)

  • Disease classification
  • 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.

  • Mat types
  • Network

The study population available in BioLINCC study data may be lower than total study enrollment due to Informed Consent restrictions and other factors.

  • 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.