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N/A N=722 Randomized Double-blind Other

Balancing Risk: Red Blood Cell Transfusion Strategies In Cardiac Surgery

Anemia

Enrolled (actual)
722
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcome: Primary: A Composite of In-hospital Postoperative Morbidity and Mortality — 59; 68 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Blood transfusion at hematocrit value less than 24% (Procedure); Blood transfusion at hematocrit value less than 28% (Procedure)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
The Cleveland Clinic
Primary completion
Aug 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
A Composite of In-hospital Postoperative Morbidity and Mortality
59; 68
SECONDARY
Length of ICU Stays
67; 66
SECONDARY
Length of Hospital Stay
10; 10
SECONDARY
Number of Blood Transfusion
1; 1
SECONDARY
Prolonged Postoperative Ventilation
22; 18
SECONDARY
Postoperative Atrial Fibrillation
33; 45

Summary

The primary purpose of this study is to determine the best blood level to begin transfusing red blood cells in individuals undergoing cardiac surgery. The secondary aim is to determine the impact of red cell transfusion on health-related quality of life following 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 and ascending aortic repair for aneurysm or dissection procedures.

Exclusion Criteria

  • Age less than 18 years
  • Congenital procedures
  • Emergencies
  • descending thoracic aortic aneurysm repairs
  • Left or right ventricular assist devices
  • Left ventricular aneurysm resections
  • Heart or lung transplantation
  • Those unable to receive blood for religious reasons
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00651573). 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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