Red Cell Storage Duration and Outcomes in Cardiac Surgery

Not Applicable

Completed

• Conditions: Blood Transfusion; Cardiac Surgery
• Interventions: Biological: Prolonged RBC storage; Biological: Short RBC storage

• Registration Number: NCT00458783
• Lead Sponsor: The Cleveland Clinic

Brief 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.

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 Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-04-09
• Study First Submitted QC: 2007-04-10
• Study First Posted: 2007-04-11
• Primary Completion: 2018-12
• Study Completion: 2019-01-16
• Status Verified: 2021-05
• Results First Submitted: 2021-05-07
• Results First Submitted QC: 2021-05-07
• Last Update Submitted: 2021-05-07
• Results First Posted: 2021-06-03
• Last Update Posted: 2021-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3942

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prolonged RBC storage	Prolonged RBC storage	Transfusion with oldest available matching RBCs.
Short RBC storage	Short RBC storage	Transfusion with youngest available matching RBCs.

Primary Outcome Measures

Name	Time	Method
Effect of RBC Age on Occurrence of Renal Failure	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.
Effect of RBC Age on Occurrence of Infection Events	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.
Effect of RBC Age on Occurrence of Atrial Fibrillation	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.
Effect of RBC Age on Occurrence of Any Reoperation	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.
Effect of RBC Age on Occurrence of Gastrointestinal Events	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.
Effect of RBC Age on Occurrence of Vascular Events	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.
Effect of RBC Age on Occurrence of Pulmonary Events.	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.
Effect of RBC Age on Occurrence of Mortality or Multisystem Organ Failure Events	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.
Effect of RBC Age on Occurrence of Asystole	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.
Primary Aim is to Determine Whether Length of Storage of Red Blood Cells is Related to Postoperative Morbid Outcomes in Patients Undergoing Cardiac Surgery.	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.
Effect of RBC Age on Occurrence of Neurologic Events	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.

Secondary Outcome Measures

Name	Time	Method
Effect of RBC Age on Postoperative Hospital Lengths of Stay.	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.
Effect of RBC Age on Intensive Care Unit (ICU) Length of Stay.	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.

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States