Protocol Details
Observational Study to Determine Red Blood Cell Alloimmunization Risk Etiology in Patients with Sickle Cell Disease
This study is currently recruiting participants.
Summary
Number |
002264-HG |
Sponsoring Institute |
National Human Genome Research Institute (NHGRI) |
Recruitment Detail |
Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 2 Years
Max Age: 99 Years |
Referral Letter Required |
Yes |
Population Exclusion(s) |
Pregnant Women;
Adults who are or may become unable to consent |
Keywords |
Sickle Cell Disease;
Transfusion;
Alloimmunization |
Recruitment Keyword(s) |
None |
Condition(s) |
Sickle Cell Disease |
Investigational Drug(s) |
None |
Investigational Device(s) |
None |
Intervention(s) |
None |
Supporting Site |
National Human Genome Research Institute |
The purpose of this research study is to look at genes and determine how they interact with each other to find changes that could explain why some people's immune systems may respond to blood transfusions. This response is called an alloimmune response. We strongly believe that when someone has an alloimmune response, it is caused by changes in their genes. We plan to compare changes in the genes of individuals that develop red blood cell alloimmunization after blood transfusions with those that do not develop alloimmunization. This may help us to create more targeted therapeutic interventions, which may improve the health of alloimmune responders.
Eligibility
INCLUSION CRITERIA
To be eligible to participate in this study, an individual must meet all of the following criteria:
1. Individual (> 2 years of age) with confirmed SCD diagnosis who meets at least one of the following conditions:
a. History of greater than ten administered transfusions or 20 transfusion units (where known)
b. History of one or more antibody screens
c. Known candidate variant genotype
EXCLUSION CRITERIA
An individual who meets any the following criteria will be excluded from participation in this study:
1. Impaired decision-making capability, with or without a legally authorized representative
2. History of transplant (e.g., organ, bone marrow, stem cell)
3. Taking immunosuppressive medications at time of enrollment
4. Confirmed pregnancy
Citations:
Not Provided
Contacts:
Clinical Trials Number:
NCT06944067