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 |
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Recruitment Status :
Completed
First Posted : August 8, 2016
Last Update Posted : March 27, 2023
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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 |
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| Thrombocytopenia Platelet Transfusion Refractoriness |
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.
| 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 |
| Group/Cohort |
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1
Previously selected HLA-alloimmunized platelet refractory, clinical, patients.
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- Corrected count increment after platelet transfusion [ Time Frame: Retrospective ]Corrected Count Increment
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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 |
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INCLUSION CRITERIA:
- Class I HLA antibodies detected by the IgG solid phase immunoassay method
- 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
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
| United States, Maryland | |
| National Institutes of Health Clinical Center | |
| Bethesda, Maryland, United States, 20892 | |
| Principal Investigator: | Willy A Flegel, M.D. | National Institutes of Health Clinical Center (CC) |
| 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: | March 27, 2023 |
| Last Verified: | December 21, 2022 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Alloimmunization Refractoriness Corrected Count Increment HLA-Compatible Natural History |
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Thrombocytopenia Blood Platelet Disorders Hematologic Diseases |