NCT03704922CompletedPhase 2/3
Age of Blood in Sickle Cell Transfusion
Age of Blood in Sickle Cell Transfusion -The Effects of Phosphotidylserine Expression on Older Red Cell Units in Adults With Sickle Cell Disease
Source: ClinicalTrials.gov · Last updated 19 Nov 2024
Brief summary (registry, in English)
The Investigators hypothesize that older red cell units trigger phagocytosis and activation of circulating macrophages with a downstream immunomodulatory cascade and release of excess Non Transferrin Bound Iron(NTBI) that leads to increased rates of infection in adults with Sickle Cell Disease(SCD). To test this hypothesis, the study staff will perform a randomized prospective clinical trial. In aim 1, the study staff will determine the biochemical differences between ≥30 day-old versus ≤10 day-old units. In aim 2, the study staff will determine the physiologic effects of the transfused blood in a patient with SCD. Lastly, in aim 3, the study staff will explore the clinical implications of receiving older red cells over a 3 month period.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 26 (actual)
- First submitted
- 5 Oct 2018
- Start date
- 4 Oct 2017
- Primary completion date
- 11 Jan 2024
- Lead sponsor
- University of North Carolina, Chapel Hill
- Diseases
- Sickle cell disease
- NCT number
- NCT03704922
What you commit to
- Study type: Interventional · Phase 2/3
- Participants enrolled: 26
- From 4 Oct 2017 to the primary completion date, 11 Jan 2024
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- history of reactions to transfusion therapy that cannot be adequately managed by antihistamines
- HIV positive
- uncontrolled inter-current illness, or psychiatric illness/social situations that would limit compliance with study requirements.
Other
- do not have crossmatch compatible red cells
- participation in another therapeutic trial for SCD
- pregnant
Who the study is looking for
- age 16 to 60 years
- have diagnosis of sickle cell disease
- receiving outpatient red cell transfusion therapy
- outpatient at the time of transfusion
Age in the registry: 16 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Emory University Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| University of North Carolina at Chapel Hill Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| Versiti Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.