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Complement (C1q) Binding to HLA Antibodies in a Solid-phase Immunoassay and Clinical Effect on Platelet Transfusion

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ClinicalTrials.gov Identifier: NCT02858323
Recruitment Status : Completed
First Posted : August 8, 2016
Last Update Posted : January 25, 2023
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC)

Brief Summary:

Background:

Platelets are blood cells that help blood clot. Some people have what is called thrombocytopenia. This means they have a low blood platelet count. They need platelet transfusions very often. Human leukocyte antigen (HLA) alloimmunization occurs for a lot of these people. They become refractory. This means their platelet levels no longer increase after transfusions. Researchers want to study a procedure that detects HLA antibodies. They want to test how well it predicts how a person will respond to a transfusion. They want to see if it does this better than the procedure that is usually used.

Objective:

To study the effect of C1q-binding of Class I HLA antibodies on platelet refractoriness in people who get platelet transfusions. To test if this method better predicts response to platelet transfusion than the IgG solid phase immunoassay method.

Eligibility:

People enrolled on protocols 11-C-0136, 08-H-0156, 03-C-0277, 01-C-0157, or 01-C-0129 who:

Agreed to have their specimens and data used for future research

Had Class I HLA antibodies detected by the IgG method

Had one or more platelet transfusions at NIH after the first positive HLA IgG antibody result

Design:

For each participant, researchers will look at a small portion of their archived plasma sample. The samples were left over from prior HLA antibody tests.

Participants samples will be analyzed. They will be tested to see if C1q-binding HLA antibodies are present. This will be done by solid phase immunoassay. Results will be compared with the past results of the IgG method.

Participants data will be stored in database that s protected by password.

...


Condition or disease
Thrombocytopenia Platelet Transfusion Refractoriness

Detailed Description:

Human leukocyte antigen (HLA) alloimmunization is common in patients undergoing frequent platelet transfusion, and is the most important cause of immune platelet refractoriness. Management strategies in HLA alloimmune platelet-refractory patients include transfusion with HLA-matched or crossmatched platelets; however, in broadly-sensitized patients, or in patients with uncommon HLA types, antigen-negative or epitope compatible donors may be difficult to find.

The Luminex immunoglobulin (Ig)G single-antigen-bead (SAB) solid phase immunoassay is now commonly used to detect HLA antibodies. However, an assay that specifically detects C1qbinding to HLA antibodies has been reported to identify a clinically relevant subset of HLA antibodies in solid organ transplantation; one group has studied the utility of this assay in platelet transfusion of HLA-alloimmunized platelet refractory patients. We intend to evaluate the ability of this C1-binding immunoassay to predict response to platelet transfusion in HLA alloimmune patients.

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Study Type : Observational
Actual Enrollment : 68 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Complement (C1q) Binding to HLA Antibodies in a Solid-Phase Immunoassay and Clinical Effect on Platelet Transfusion
Study Start Date : July 27, 2016
Actual Primary Completion Date : June 20, 2017
Actual Study Completion Date : June 20, 2017

Resource links provided by the National Library of Medicine


Group/Cohort
1
Previously selected HLA-alloimmunized platelet refractory, clinical, patients.



Primary Outcome Measures :
  1. Corrected count increment after platelet transfusion [ Time Frame: Retrospective ]
    Corrected Count Increment



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Criteria
  • INCLUSION CRITERIA:

    1. Class I HLA antibodies detected by the IgG solid phase immunoassay method
    2. Greater than or equal to 1 episode of platelet transfusion at NIH after the first positive HLA IgG antibody result

EXCLUSION CRITERIA:

1) Hyperproliferative thrombocytopenia


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02858323


Locations
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United States, Maryland
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
Investigators
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Principal Investigator: Willy A Flegel, M.D. National Institutes of Health Clinical Center (CC)
Publications:
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Responsible Party: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT02858323    
Other Study ID Numbers: 999916155
16-CC-N155
First Posted: August 8, 2016    Key Record Dates
Last Update Posted: January 25, 2023
Last Verified: December 21, 2022
Keywords provided by National Institutes of Health Clinical Center (CC):
Alloimmunization
Refractoriness
Corrected Count Increment
HLA-Compatible
Natural History
Additional relevant MeSH terms:
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Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases