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

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

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.

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)

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

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.