Red Cell Storage Duration and Outcomes in Cardiac Surgery

May 7, 2021 updated by: The Cleveland Clinic
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

3942

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Prolonged RBC storage
Transfusion with oldest available matching RBCs.
Biological: Prolonged RBC storage
Transfusion with oldest available matching RBCs
Active Comparator: Short RBC storage
Transfusion with youngest available matching RBCs.
Biological: Short RBC storage
Transfusion with youngest available matching RBCs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
The primary composite endpoint was the occurrence of mortality or multisystem organ failure, cardiac events (ventricular tachycardia, fibrillation, or asystole; atrial fibrillation), pulmonary events (pneumonia, prolonged postoperative ventilation, pulmonary embolus), neurologic events (stroke, coma), renal failure, infection (deep sternal wound infection, sepsis), gastrointestinal events (ischemia, infarction), any reoperation (for bleeding, tamponade, cardiac dysfunction), and vascular events (dissection, limb ischemia), as defined for the STS database.
30 days post surgery.
Effect of RBC Age on Occurrence of Mortality or Multisystem Organ Failure Events
Time Frame: 30 days post surgery
Aim is to Determine Whether Length of Storage of Red Blood Cells is Related to Postoperative Mortality or Multisystem Organ Failure events in Patients Undergoing Cardiac Surgery.
30 days post surgery
Effect of RBC Age on Occurrence of Neurologic Events
Time Frame: 30 days post surgery.
Neurologic events includes stroke and coma. Aim is to Determine Whether Length of Storage of Red Blood Cells is Related to Postoperative Mortality or Neurologic events in Patients Undergoing Cardiac Surgery.
30 days post surgery.
Effect of RBC Age on Occurrence of Pulmonary Events.
Time Frame: 30 days post surgery.

Aim is to Determine Whether Length of Storage of Red Blood Cells is Related to Postoperative Pulmonary events in Patients Undergoing Cardiac Surgery.

Pulmonary events include pneumonia, prolonged postoperative ventilation and pulmonary embolus.
30 days post surgery.
Effect of RBC Age on Occurrence of Renal Failure
Time Frame: 30 days post surgery.
Aim is to Determine Whether Length of Storage of Red Blood Cells is Related to Postoperative Renal Failure in Patients Undergoing Cardiac Surgery.
30 days post surgery.
Effect of RBC Age on Occurrence of Infection Events
Time Frame: 30 days post surgery.

Aim is to Determine Whether Length of Storage of Red Blood Cells is Related to Postoperative Infection events in Patients Undergoing Cardiac Surgery.

Infection events include deep sternal wound infection and sepsis.
30 days post surgery.
Effect of RBC Age on Occurrence of Atrial Fibrillation
Time Frame: 30 days post surgery.
Aim is to Determine Whether Length of Storage of Red Blood Cells is Related to Postoperative Atrial fibrillation in Patients Undergoing Cardiac Surgery.
30 days post surgery.
Effect of RBC Age on Occurrence of Asystole
Time Frame: 30 days post surgery.
Aim is to Determine Whether Length of Storage of Red Blood Cells is Related to Postoperative Asystole in Patients Undergoing Cardiac Surgery.
30 days post surgery.
Effect of RBC Age on Occurrence of Gastrointestinal Events
Time Frame: 30 days post surgery.

Aim is to Determine Whether Length of Storage of Red Blood Cells is Related to Postoperative Gastrointestinal events in Patients Undergoing Cardiac Surgery.

Gastrointestinal events include ischemia and infarction.
30 days post surgery.
Effect of RBC Age on Occurrence of Any Reoperation
Time Frame: 30 days post surgery.

Aim is to Determine Whether Length of Storage of Red Blood Cells is Related to any Postoperative Reoperation in Patients Undergoing Cardiac Surgery.

Reoperation for bleeding, tamponade and cardiac dysfunction.
30 days post surgery.
Effect of RBC Age on Occurrence of Vascular Events
Time Frame: 30 days post surgery.

Aim is to Determine Whether Length of Storage of Red Blood Cells is Related to Postoperative Vascular events in Patients Undergoing Cardiac Surgery.

Vascular events include dissection and limb ischemia.
30 days post surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of RBC Age on Intensive Care Unit (ICU) Length of Stay.
Time Frame: The total hours from start to end in the Intensive Care Unit (ICU).
Aim is to Determine Whether Length of Storage of Red Blood Cells is Related to Intensive Care Unit (ICU) Length of Stay in Patients Undergoing Cardiac Surgery.
The total hours from start to end in the Intensive Care Unit (ICU).
Effect of RBC Age on Postoperative Hospital Lengths of Stay.
Time Frame: The total days from start to end of the Hospital Stay.
Aim is to Determine Whether Length of Storage of Red Blood Cells is Related to Postoperative Hospital Lengths of Stay in Patients Undergoing Cardiac Surgery.
The total days from start to end of the Hospital Stay.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Investigators

  • Principal Investigator: Andra Duncan, MD, The Cleveland Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

January 16, 2019

Study Registration Dates

First Submitted

April 9, 2007

First Submitted That Met QC Criteria

April 10, 2007

First Posted (Estimate)

April 11, 2007

Study Record Updates

Last Update Posted (Actual)

June 3, 2021

Last Update Submitted That Met QC Criteria

May 7, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 07-140

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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