CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,481 enrolled
Drug / intervention
Red blood cell units stored <= 10 days +1 morebiological
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/NCT00991341
NCT00991341Phase 3Completed
CompareCT.gov

Red Cell Storage Duration Study

Carelon Research·interventional·Posted Oct 8, 2009·Updated Jun 9, 2015

In Brief

A Phase 3 clinical trial evaluating Red blood cell units stored <= 10 days and Red blood cell units stored >= 21 days for Cardiac Surgery and Erythrocyte Transfusion. Completed, enrolled 1,481 participants across 33 sites.

Detailed Summary

The RECESS study will compare the effects of transfusing red blood cell units stored \<= 10 days vs. red blood cell units stored \>= 21 days, in patients who are undergoing complex cardiac surgery and are likely to need a red blood cell transfusion. The primary hypothesis is that there is a clinically important difference between the effects of shorter-storage red cell units and longer-storage red cell units on clinical outcomes and mortality risk.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCardiac Surgery, Erythrocyte Transfusion
CountriesUnited States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI)

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 8, 2009
Enrollment StartJan 1, 2010
Primary CompletionMar 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 16.7 years ago

Interventions

Red blood cell units stored <= 10 daysbiological

Pre-storage leukoreduced red blood cell units stored \<=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.

Red blood cell units stored >= 21 daysbiological

Pre-storage leukoreduced red blood cell units stored \>=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.