Balancing Risk: Red Blood Cell Transfusion Strategies In Cardiac Surgery

NCT00651573 | Completed Results DMC

• 1 other identifier: 08-064
• Study Type: interventional
• Target: 722
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Anemia

Keywords

Surgery; Cardiopulmonary bypass; Coronary artery bypass graft; Valve procedure; Hematocrit level; Outcomes

Outcome Measures

Primary Outcomes (1)

• A Composite of In-hospital Postoperative Morbidity and Mortality

  The composite components were in-hospital mortality, neurologic morbidity (stroke or coma), pulmonary morbidity (pneumonia, pulmonary embolus, or prolonged postoperative ventilation \[\>24 hours\]), renal morbidity (renal failure), infectious morbidity (deep sternal wound infection, septicemia, or sepsis), cardiac arrhythmia (atrial fibrillation, ventricular tachycardia, fibrillation, or asystole), gastrointestinal morbidity, reoperation (for bleeding, tamponade, graft occlusion, valve dysfunction, or noncardiac reasons), and vascular morbidity (aortic or femoral artery dissection or acute limb ischemia).

  After surgery until hosptal discharge

Secondary Outcomes (5)

• Length of ICU Stays

  After surgery until discharged from ICU

• Length of Hospital Stay

  After surgery until hospital discharge

• Number of Blood Transfusion

  From induction to the end of sugery

• Prolonged Postoperative Ventilation

  After surgeyr until hospital discharge

• Postoperative Atrial Fibrillation

  After surgery until hospital discharge

Study Arms (2)

Blood transfusion triggers of 24% hematocrit value

ACTIVE COMPARATOR

Red blood cell transfusion will be given when hematocrit values fall below the assigned group 1 value which is 24%. When the hematocrit value falls to less 24%, a 1 unit RBC transfusion will be administered. Following administration of the 1 unit transfusion a repeat HCT is performed; if the hematocrit value responds to transfusion and is greater than or equal to 24%, no further transfusions will be administered.

Procedure: Blood transfusion at hematocrit value less than 24%

Blood transfusion triggers of 28% hematocrit value

ACTIVE COMPARATOR

Red blood cell transfusion will be given when hematocrit values fall below the assigned group 1 value which is 28%. When the hematocrit value falls to less 28%, a 1 unit RBC transfusion will be administered. Following administration of the 1 unit transfusion a repeat HCT is performed; if the hematocrit value responds to transfusion and is greater than or equal to 28%, no further transfusions will be administered.

Procedure: Blood transfusion at hematocrit value less than 28%

Interventions

Blood transfusion at hematocrit value less than 24% PROCEDURE

transfusion

Blood transfusion triggers of 24% hematocrit value

Blood transfusion at hematocrit value less than 28% PROCEDURE

transfusion

Blood transfusion triggers of 28% hematocrit value

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (2)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

S.A.L. Hospital and Medical Institute

Ahmedabad, Thaltej,, 380054, India

Location

Related Publications (2)

• Carson JL, Stanworth SJ, Dennis JA, Fergusson DA, Pagano MB, Roubinian NH, Turgeon AF, Valentine S, Trivella M, Doree C, Hebert PC. Transfusion thresholds and other strategies for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2025 Oct 20;10(10):CD002042. doi: 10.1002/14651858.CD002042.pub6.

  PMID: 41114449 DERIVED

• Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Doree C, Hebert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002042. doi: 10.1002/14651858.CD002042.pub5.

  PMID: 34932836 DERIVED

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Daniel Sessler, MD
• Organization: Cleveland Clinic Foundation

ds@or.org

216-4444900

Study Officials

• Daniel I Sessler, MD

  The Cleveland Clinic

  STUDY CHAIR

• Daniel I Sessler, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2008
• First Posted: April 3, 2008
• Study Start: March 1, 2007
• Primary Completion: August 1, 2014
• Study Completion: January 3, 2019
• Last Updated: June 14, 2019
• Results First Posted: June 14, 2019

Record last verified: 2019-03

Locations

US (1); IN (1)