Red Cell Storage Duration and Outcomes in Cardiac Surgery

This study is currently recruiting participants.

Verified January 2013 by Outcomes Research Consortium

Sponsor:

Information provided by (Responsible Party):

Colleen Koch, Outcomes Research Consortium

ClinicalTrials.gov Identifier:

NCT00458783

First received: April 9, 2007

Last updated: January 28, 2013

Last verified: January 2013

History of Changes

Purpose

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.

Condition	Intervention
Blood Transfusion Cardiac Surgery	Procedure: Blood transfusion

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor)
Official Title:	Red Cell Storage Duration and Outcomes in Cardiac Surgery

Resource links provided by NLM:

MedlinePlus related topics: Blood Transfusion and Donation Heart Surgery

U.S. FDA Resources

Further study details as provided by Outcomes Research Consortium:

Primary Outcome Measures:

Primary aim is to determine whether length of storage of Red Blood Cells is related to postoperative morbid outcomes in patients undergoing cardiac surgery. [ Time Frame: 30 days post surgery. ] [ Designated as safety issue: No ]

Estimated Enrollment:	2800
Study Start Date:	April 2007
Estimated Study Completion Date:	February 2014
Estimated Primary Completion Date:	February 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: red blood cells stored longer than 20 days Red blood cell transfusion with blood cell storage duration more than 20 days.	Procedure: Blood transfusion Blood transfusion during cardiac surgery with blood storage duration of more than 20 days.
Active Comparator: red blood cells stored less than 14 days Red blood cell transfusion with blood cell storage duration less than 14 days.	Procedure: Blood transfusion Red blood cell transfusion with a storage duration of less than 14 days.

Detailed Description:

Subjects undergoing cardiac surgery will be randomized into one of two groups. Group A will receive transfused blood that has storage duration less than 14 days. Group B will receive transfused blood with a storage duration of more than 20 days.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00458783

Contacts

Contact: Babak Kashy, MD	216-445-0998	kashyb@ccf.org
Contact: Gretchen Upton	216-444-3289	uptong@ccf.org

Locations

United States, Ohio
Cleveland Clinic	Recruiting
Cleveland, Ohio, United States, 44195
Principal Investigator: Colleen G Koch, MD MS

Sponsors and Collaborators

Outcomes Research Consortium

Investigators

Principal Investigator:

Colleen G Koch, MD MS

The Cleveland Clinic

More Information

No publications provided

Responsible Party:	Colleen Koch, Principal Investigator, Outcomes Research Consortium
ClinicalTrials.gov Identifier:	NCT00458783 History of Changes
Other Study ID Numbers:	07-140
Study First Received:	April 9, 2007
Last Updated:	January 28, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Outcomes Research Consortium:

Transfusion
Cardiac
Blood storage duration

ClinicalTrials.gov processed this record on May 19, 2013

To Top