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Red Cell Storage Duration Study | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Red Cell Storage Duration Study

NCT00991341•Carelon Research

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.

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•\>= 12 years old
•\>= 40 kg body weight
•Scheduled complex cardiac surgery with planned use of median sternotomy.
•Patients ≥ 18 years must have a Transfusion Risk Understanding Scoring Tool (TRUST) probability score ≥ 3

Exclusion Criteria

•Refusal of blood products
•Planned surgery is minimally invasive
•Known transfusion reaction history
•Requirement for washed products, volume reduced products, or products with additive solution removed
•Expected residual cyanosis with O2 saturation \< 90
•Left ventricular assist device (LVAD) or Extracorporeal membrane oxygenation (ECMO) support pre-operatively or planned need post-operatively
•Cardiogenic shock requiring pre-operative placement of an Intra-aortic balloon pump (IABP) (IABP done for unstable angina or prophylactically for low ejection fraction is not excluded)
•Planned Deep Hypothermic Circulatory Arrest (DHCA)
•Renal dysfunction requiring pre-operative renal replacement therapies such as hemodialysis (HD) or continuous venovenous hemofiltration (CVVH)
•Planned use of alternative to heparin, e.g. bivalirudin
+3 more criteria

Locations (33)

University of Florida

Gainesville, Florida, United States

Emory University

Atlanta, Georgia, United States

St. Joseph Hospital

Fort Wayne, Indiana, United States

Indiana/Ohio Heart

Fort Wayne, Indiana, United States

University of Iowa

Iowa City, Iowa, United States

University of Maryland

Baltimore, Maryland, United States

Johns Hopkins University

Baltimore, Maryland, United States

Brigham & Women's Hospital

Boston, Massachusetts, United States

Children's Hospital Boston

Boston, Massachusetts, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Key Dates

Start Date

January 1, 2010

Primary Completion Date

March 1, 2014

Completion Date

March 1, 2014

Last Updated

June 9, 2015

Enrollment

1,481

ACTUAL participants

Conditions

Cardiac SurgeryErythrocyte Transfusion

Interventions

Red blood cell units stored <= 10 days

BIOLOGICAL

Red blood cell units stored >= 21 days

BIOLOGICAL

Prognostic Value of Novel Biomarkers on Adverse Renal Outcomes in High-Risk Cardiac Surgery Patients

NCT07418242

Cardiac Surgery Associated - Acute Kidney InjuryCritical Illness

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RECRUITINGNA

Diagnosis of Postoperative Atrial Fibrillation by a Smartwatch

NCT05573633

Atrial FibrillationCardiac Surgery

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 9, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Red Cell Storage Duration Study

Inclusion Criteria

Exclusion Criteria

Prognostic Value of Novel Biomarkers on Adverse Renal Outcomes in High-Risk Cardiac Surgery Patients

Diagnosis of Postoperative Atrial Fibrillation by a Smartwatch

Colchicine's Effect on Inflammatory Markers

Submaximal Cardiopulmonary Exercise Testing for Detection of Myocardial Injury After Noncardiac Surgery

Difficult Airway Incidence in Cardiovascular Surgery and a Prediction Model Development

LSALT Peptide for Prevention or Attenuation of Acute Kidney Injury (AKI) in Patients Undergoing On-Pump Cardiac Surgery