Red Cell Storage Duration and Outcomes in Cardiac Surgery

Cardiac Surgery Clinical Trial

Official title:

Red Cell Storage Duration and Outcomes in Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00458783
• Other study ID #: 07-140
• Status: Completed
• Phase: N/A
• Start date: April 2007
• Est. completion date: January 16, 2019

Study information

• Verified date: May 2021
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3942
• Est. completion date: January 16, 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Transfusion
• Cardiac Surgery

Intervention

Biological:
• Prolonged RBC storage
Transfusion with oldest available matching RBCs
• Short RBC storage
Transfusion with youngest available matching RBCs

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Aim is to Determine Whether Length of Storage of Red Blood Cells is Related to Postoperative Morbid Outcomes in Patients Undergoing Cardiac 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.
Primary	Effect of RBC Age on Occurrence of Mortality or Multisystem Organ Failure Events	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
Primary	Effect of RBC Age on Occurrence of Neurologic Events	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.
Primary	Effect of RBC Age on Occurrence of Pulmonary Events.	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.
Primary	Effect of RBC Age on Occurrence of Renal Failure	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.
Primary	Effect of RBC Age on Occurrence of Infection Events	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.
Primary	Effect of RBC Age on Occurrence of Atrial Fibrillation	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.
Primary	Effect of RBC Age on Occurrence of Asystole	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.
Primary	Effect of RBC Age on Occurrence of Gastrointestinal Events	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.
Primary	Effect of RBC Age on Occurrence of Any Reoperation	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.
Primary	Effect of RBC Age on Occurrence of Vascular Events	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	Effect of RBC Age on Intensive Care Unit (ICU) Length of Stay.	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).
Secondary	Effect of RBC Age on Postoperative Hospital Lengths of 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.