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N/A N=3,835 Randomized Double-blind Other

Red Cell Storage Duration and Outcomes in Cardiac Surgery

Blood Transfusion · Cardiac Surgery

Enrolled (actual)
3,835
Serious AEs
52.1%
Results posted
Jun 2021
Primary outcome: Primary: Primary Aim is to Determine Whether Length of Storage of Red Blood Cells is Related to Postoperative Morbid Outcomes in Patients Undergoing Cardiac Surgery. — 360; 362 Participants — p=0.08

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Prolonged RBC storage (Biological); Short RBC storage (Biological)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
The Cleveland Clinic
Primary completion
Dec 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Primary Aim is to Determine Whether Length of Storage of Red Blood Cells is Related to Postoperative Morbid Outcomes in Patients Undergoing Cardiac Surgery.
360; 362 0.08
PRIMARY
Effect of RBC Age on Occurrence of Mortality or Multisystem Organ Failure Events
24; 16
PRIMARY
Effect of RBC Age on Occurrence of Neurologic Events
19; 14
PRIMARY
Effect of RBC Age on Occurrence of Pulmonary Events.
113; 106
PRIMARY
Effect of RBC Age on Occurrence of Renal Failure
36; 32
PRIMARY
Effect of RBC Age on Occurrence of Infection Events
12; 10
PRIMARY
Effect of RBC Age on Occurrence of Atrial Fibrillation
238; 258
PRIMARY
Effect of RBC Age on Occurrence of Asystole
29; 13
PRIMARY
Effect of RBC Age on Occurrence of Gastrointestinal Events
33; 28
PRIMARY
Effect of RBC Age on Occurrence of Any Reoperation
81; 69
PRIMARY
Effect of RBC Age on Occurrence of Vascular Events
9; 7
SECONDARY
Effect of RBC Age on Intensive Care Unit (ICU) Length of Stay.
54; 51 0.9
SECONDARY
Effect of RBC Age on Postoperative Hospital Lengths of Stay.
9; 9 0.07

Summary

The purpose of this study is to determine whether length of storage of RBC is related to postoperative morbid outcomes in patients undergoing cardiac surgery.

Eligibility Criteria

Inclusion Criteria

  • All primary and reoperative adult cardiac surgical patients undergoing cardiopulmonary bypass for coronary artery bypass grafting, coronary artery bypass grafting with a valve procedure, isolated valve procedures, ascending aortic aneurysm or dissection repair alone or combined with CABG and valve procedures

Exclusion Criteria

  • Age less than 18 years
  • Descending thoracic aortic aneurysm repairs
  • Left or right ventricular assist devices
  • Those unable to receive blood for religious reasons
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00458783). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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