Trial Outcomes & Findings for Red Cell Storage Duration and Outcomes in Cardiac Surgery (NCT NCT00458783)

NCT ID: NCT00458783

Last Updated: 2021-06-03

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 3942 participants
• Primary outcome timeframe: 30 days post surgery.
• Results posted on: 2021-06-03

Participant Flow

From July 2007 to May 2016, 3942 adults undergoing coronary artery bypass grafting, cardiac valve procedures, or ascending aorta repair, either alone or in combination were enrolled in the study. 3835 adults were randomized to transfusion of RBCs stored for ≤ 14 days (younger units) or for ≥ 20 days (older units) intraoperatively and throughout the postoperative hospitalization

Participant milestones

Measure	Prolonged RBC Storage Transfusion with oldest available matching RBCs. Prolonged RBC storage: Transfusion with oldest available matching RBCs	Short RBC Storage Transfusion with youngest available matching RBCs. Short RBC storage: Transfusion with youngest available matching RBCs
Overall Study STARTED	1914	1921
Overall Study COMPLETED	686	701
Overall Study NOT COMPLETED	1228	1220

Reasons for withdrawal

Measure	Prolonged RBC Storage Transfusion with oldest available matching RBCs. Prolonged RBC storage: Transfusion with oldest available matching RBCs	Short RBC Storage Transfusion with youngest available matching RBCs. Short RBC storage: Transfusion with youngest available matching RBCs
Overall Study Protocol Violation	1228	1220

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Prolonged RBC Storage n=686 Participants Transfusion with oldest available matching RBCs. Prolonged RBC storage: Transfusion with oldest available matching RBCs	Short RBC Storage n=701 Participants Transfusion with youngest available matching RBCs. Short RBC storage: Transfusion with youngest available matching RBCs	Total n=1387 Participants Total of all reporting groups
Age, Continuous	70 years STANDARD_DEVIATION 12 • n=686 Participants	69 years STANDARD_DEVIATION 12 • n=701 Participants	69 years STANDARD_DEVIATION 12 • n=1387 Participants
Sex: Female, Male Female	326 Participants n=686 Participants	381 Participants n=701 Participants	707 Participants n=1387 Participants
Sex: Female, Male Male	360 Participants n=686 Participants	320 Participants n=701 Participants	680 Participants n=1387 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Body mass index	28 kg/m2 STANDARD_DEVIATION 5.9 • n=686 Participants	28 kg/m2 STANDARD_DEVIATION 5.9 • n=701 Participants	28 kg/m2 STANDARD_DEVIATION 5.9 • n=1387 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Prolonged RBC Storage n=686 Participants Transfusion with oldest available matching RBCs. Prolonged RBC storage: Transfusion with oldest available matching RBCs	Short RBC Storage n=701 Participants Transfusion with youngest available matching RBCs. Short RBC storage: Transfusion with youngest available matching RBCs
Primary Aim is to Determine Whether Length of Storage of Red Blood Cells is Related to Postoperative Morbid Outcomes in Patients Undergoing Cardiac Surgery.	360 Participants	362 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Prolonged RBC Storage n=686 Participants Transfusion with oldest available matching RBCs. Prolonged RBC storage: Transfusion with oldest available matching RBCs	Short RBC Storage n=701 Participants Transfusion with youngest available matching RBCs. Short RBC storage: Transfusion with youngest available matching RBCs
Effect of RBC Age on Occurrence of Mortality or Multisystem Organ Failure Events	24 Participants	16 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Prolonged RBC Storage n=686 Participants Transfusion with oldest available matching RBCs. Prolonged RBC storage: Transfusion with oldest available matching RBCs	Short RBC Storage n=701 Participants Transfusion with youngest available matching RBCs. Short RBC storage: Transfusion with youngest available matching RBCs
Effect of RBC Age on Occurrence of Neurologic Events	19 Participants	14 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Prolonged RBC Storage n=686 Participants Transfusion with oldest available matching RBCs. Prolonged RBC storage: Transfusion with oldest available matching RBCs	Short RBC Storage n=701 Participants Transfusion with youngest available matching RBCs. Short RBC storage: Transfusion with youngest available matching RBCs
Effect of RBC Age on Occurrence of Pulmonary Events.	113 Participants	106 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Prolonged RBC Storage n=686 Participants Transfusion with oldest available matching RBCs. Prolonged RBC storage: Transfusion with oldest available matching RBCs	Short RBC Storage n=701 Participants Transfusion with youngest available matching RBCs. Short RBC storage: Transfusion with youngest available matching RBCs
Effect of RBC Age on Occurrence of Renal Failure	36 Participants	32 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Prolonged RBC Storage n=686 Participants Transfusion with oldest available matching RBCs. Prolonged RBC storage: Transfusion with oldest available matching RBCs	Short RBC Storage n=701 Participants Transfusion with youngest available matching RBCs. Short RBC storage: Transfusion with youngest available matching RBCs
Effect of RBC Age on Occurrence of Infection Events	12 Participants	10 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Prolonged RBC Storage n=686 Participants Transfusion with oldest available matching RBCs. Prolonged RBC storage: Transfusion with oldest available matching RBCs	Short RBC Storage n=701 Participants Transfusion with youngest available matching RBCs. Short RBC storage: Transfusion with youngest available matching RBCs
Effect of RBC Age on Occurrence of Atrial Fibrillation	238 Participants	258 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Prolonged RBC Storage n=686 Participants Transfusion with oldest available matching RBCs. Prolonged RBC storage: Transfusion with oldest available matching RBCs	Short RBC Storage n=701 Participants Transfusion with youngest available matching RBCs. Short RBC storage: Transfusion with youngest available matching RBCs
Effect of RBC Age on Occurrence of Asystole	29 Participants	13 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Prolonged RBC Storage n=686 Participants Transfusion with oldest available matching RBCs. Prolonged RBC storage: Transfusion with oldest available matching RBCs	Short RBC Storage n=701 Participants Transfusion with youngest available matching RBCs. Short RBC storage: Transfusion with youngest available matching RBCs
Effect of RBC Age on Occurrence of Gastrointestinal Events	33 Participants	28 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Prolonged RBC Storage n=686 Participants Transfusion with oldest available matching RBCs. Prolonged RBC storage: Transfusion with oldest available matching RBCs	Short RBC Storage n=701 Participants Transfusion with youngest available matching RBCs. Short RBC storage: Transfusion with youngest available matching RBCs
Effect of RBC Age on Occurrence of Any Reoperation	81 Participants	69 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Prolonged RBC Storage n=686 Participants Transfusion with oldest available matching RBCs. Prolonged RBC storage: Transfusion with oldest available matching RBCs	Short RBC Storage n=701 Participants Transfusion with youngest available matching RBCs. Short RBC storage: Transfusion with youngest available matching RBCs
Effect of RBC Age on Occurrence of Vascular Events	9 Participants	7 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Prolonged RBC Storage n=686 Participants Transfusion with oldest available matching RBCs. Prolonged RBC storage: Transfusion with oldest available matching RBCs	Short RBC Storage n=701 Participants Transfusion with youngest available matching RBCs. Short RBC storage: Transfusion with youngest available matching RBCs
Effect of RBC Age on Intensive Care Unit (ICU) Length of Stay.	54 Hours Interval 29.0 to 114.0	51 Hours Interval 28.0 to 113.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Prolonged RBC Storage n=686 Participants Transfusion with oldest available matching RBCs. Prolonged RBC storage: Transfusion with oldest available matching RBCs	Short RBC Storage n=701 Participants Transfusion with youngest available matching RBCs. Short RBC storage: Transfusion with youngest available matching RBCs
Effect of RBC Age on Postoperative Hospital Lengths of Stay.	9 Days Interval 7.0 to 13.0	9 Days Interval 7.0 to 13.0

Adverse Events

Prolonged RBC Storage

Serious events: 360 serious events

Other events: 0 other events

Deaths: 23 deaths

Short RBC Storage

Serious events: 362 serious events

Other events: 0 other events

Deaths: 15 deaths

Serious adverse events

Measure	Prolonged RBC Storage n=686 participants at risk Transfusion with oldest available matching RBCs. Prolonged RBC storage: Transfusion with oldest available matching RBCs	Short RBC Storage n=701 participants at risk Transfusion with youngest available matching RBCs. Short RBC storage: Transfusion with youngest available matching RBCs
General disorders Multisystem organ failure	0.44% 3/686 • 30 days post surgery.	0.43% 3/701 • 30 days post surgery.
Nervous system disorders Stroke	0.87% 6/686 • 30 days post surgery.	1.00% 7/701 • 30 days post surgery.
Nervous system disorders Coma	2.0% 14/686 • 30 days post surgery.	1.3% 9/701 • 30 days post surgery.
Respiratory, thoracic and mediastinal disorders Pneumonia	2.0% 14/686 • 30 days post surgery.	1.3% 9/701 • 30 days post surgery.
Respiratory, thoracic and mediastinal disorders Prolonged ventilation	15.6% 107/686 • 30 days post surgery.	14.1% 99/701 • 30 days post surgery.
Renal and urinary disorders Renal morbidity	5.2% 36/686 • 30 days post surgery.	4.6% 32/701 • 30 days post surgery.
Infections and infestations Deep sternal wound infection	0.29% 2/686 • 30 days post surgery.	0.43% 3/701 • 30 days post surgery.
Immune system disorders Septicemia/sepsis	1.5% 10/686 • 30 days post surgery.	1.00% 7/701 • 30 days post surgery.
Cardiac disorders Atrial fibrillation	34.7% 238/686 • 30 days post surgery.	36.8% 258/701 • 30 days post surgery.
Cardiac disorders Asystole	4.2% 29/686 • 30 days post surgery.	1.9% 13/701 • 30 days post surgery.
Gastrointestinal disorders Gastrointestinal morbidity	4.8% 33/686 • 30 days post surgery.	4.0% 28/701 • 30 days post surgery.
Surgical and medical procedures Bleeding/tamponade	6.4% 44/686 • 30 days post surgery.	5.1% 36/701 • 30 days post surgery.
Surgical and medical procedures Graft occlusion/valve dysfunction, noncardiac reasons	6.9% 47/686 • 30 days post surgery.	5.8% 41/701 • 30 days post surgery.
Vascular disorders Aortic or femoral artery dissection	0.15% 1/686 • 30 days post surgery.	0.00% 0/701 • 30 days post surgery.
Vascular disorders Acute limb ischemia	1.2% 8/686 • 30 days post surgery.	1.00% 7/701 • 30 days post surgery.

Other adverse events

Adverse event data not reported

Additional Information

Andra Duncan, MD

Cleveland Clinic

Phone: 216-445-2372

Email: duncana@ccf.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place