CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 26 enrolled
Drug / intervention
Transfusionbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03704922
NCT03704922Phase 3Completed

Age of Blood in Sickle Cell Transfusion -The Effects of Phosphotidylserine Expression on Older Red Cell Units in Adults With Sickle Cell Disease

University of North Carolina, Chapel Hill·interventional·Posted Oct 15, 2018·Updated Nov 19, 2024

In Brief

A Phase 3 clinical trial evaluating Transfusion for Sickle Cell Disease. Completed, enrolled 26 participants across 3 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedOct 15, 2018
Enrollment StartOct 4, 2017
Primary CompletionJan 11, 2024
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 7.7 years ago

Interventions

Transfusionbiological

Red cell units for transfusion