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RBC survival in patients with SCD for Thalassemia

Phase < 1
Recruiting
Led By John F Tisdale, M.D.
Research Sponsored by National Heart, Lung, and Blood Institute (NHLBI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up patients w/o transplant: lab draw every 2 weeks until biotin-labeled cells are no longer detected. patients post-transplant: lab draw every four weeks, until week 12. lab draw every 2 weeks until biotin-labeled cells are no longer detected.
Awards & highlights

Study Summary

"This trial aims to determine the lifespan of red blood cells in patients with sickle cell disease and other blood disorders, before and after receiving treatments such as stem cell transplantation. The study will use a labeling

Who is the study for?
This trial is for individuals with sickle cell disease or other hemoglobin disorders like thalassemia. It's open to those who are on disease-modifying treatments or have had a stem cell transplant. The study aims to understand how long their red blood cells live using biotin labeling.Check my eligibility
What is being tested?
The trial tests the lifespan of red blood cells in patients with sickle cell and related disorders by marking them with biotin, a vitamin. Researchers will compare this before and after treatments like transplants, looking at how different therapies affect red cell survival.See study design
What are the potential side effects?
Since the intervention involves labeling cells with biotin, which is generally considered safe and is a common dietary supplement, significant side effects are not expected. However, individual reactions may vary.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~patients w/o transplant: lab draw every 2 weeks until biotin-labeled cells are no longer detected. patients post-transplant: lab draw every four weeks, until week 12. lab draw every 2 weeks until biotin-labeled cells are no longer detected.
This trial's timeline: 3 weeks for screening, Varies for treatment, and patients w/o transplant: lab draw every 2 weeks until biotin-labeled cells are no longer detected. patients post-transplant: lab draw every four weeks, until week 12. lab draw every 2 weeks until biotin-labeled cells are no longer detected. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To determine and compare red blood cell survival, by virtue of the mean number of days of detectable biotin-labeled RBCs, in participants with SCD and/or other hemoglobinopathies.
Secondary outcome measures
Validate the association of RBC survival with known markers of increased survival.

Trial Design

1Treatment groups
Experimental Treatment
Group I: RBC survival in patients with SCDExperimental Treatment1 Intervention
RBC lifespan, determined by the mean number of days from biotin-labeled RBC infusion until biotin-labeled RBCs are below limit of detection, in patients with inherited hemoglobinopathies prior to and post initiation of disease modifying therapy or HSCT

Find a Location

Who is running the clinical trial?

Children's National Research InstituteOTHER
211 Previous Clinical Trials
208,057 Total Patients Enrolled
1 Trials studying Thalassemia
27 Patients Enrolled for Thalassemia
National Heart, Lung, and Blood Institute (NHLBI)Lead Sponsor
3,841 Previous Clinical Trials
47,814,005 Total Patients Enrolled
28 Trials studying Thalassemia
3,312 Patients Enrolled for Thalassemia
John F Tisdale, M.D.Principal InvestigatorNational Heart, Lung, and Blood Institute (NHLBI)
14 Previous Clinical Trials
1,227 Total Patients Enrolled
1 Trials studying Thalassemia
90 Patients Enrolled for Thalassemia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which specific criteria determine the eligibility of individuals for participation in this clinical trial?

"Individuals aged between 18 and 100 with a confirmed diagnosis of sickle cell disease are eligible to participate in this research. The trial aims to enroll approximately 100 participants."

Answered by AI

Are there any available vacancies for potential participants in this research study?

"As documented on clinicaltrials.gov, the ongoing medical investigation is not actively seeking participants. The trial was initially listed on 3/20/2024 and last revised on 3/14/2024. Despite this particular study being inactive in terms of recruitment, there are presently 244 alternative trials open for patient enrollment."

Answered by AI

Are individuals aged 55 and above being actively sought for enrollment in this research study?

"Eligible candidates for this research must be between 18 and 100 years old. Among the available clinical trials, there are 167 studies catering to individuals under 18 years of age and 95 focused on those over 65."

Answered by AI
~67 spots leftby May 2029