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Study to Understand the Genetic Risk of Developing an Immune Response After Blood Transfusions Among Individuals With Sickle Cell Disease

Observational Study to Determine Red Blood Cell Alloimmunization Risk Etiology in Patients With Sickle Cell Disease

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
2 Years to 99 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at gene changes that may explain why some people with sickle cell disease have an immune reaction to donated blood. It compares the genes of people who have this reaction after blood transfusions with those who do not.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Must be older than 2 and have a confirmed diagnosis of sickle cell disease.
  • Must also meet at least one of these conditions: have had more than 10 blood transfusions or 20 units of blood, if known; have had at least one antibody screen (a blood test for signs of an immune response); or have a known gene change being studied.

Who can't join

  • Have trouble making decisions, even if someone is legally allowed to make decisions for you.
  • Have had an organ, bone marrow, or stem cell transplant.
  • Are taking medicines that weaken the immune system when joining the study.
  • Have a confirmed pregnancy.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

* 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: 1. History of greater than ten administered transfusions or 20 transfusion units (where known) 2. History of one or more antibody screens 3. 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

Study sites (1)

MD