Clinical trial NCT00458783: Red Cell Storage Duration and Outcomes in Cardiac Surgery
Official title: Red Cell Storage Duration and Outcomes in Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Transfusion
Cardiac Surgery
Keywords: Transfusion
Cardiac
Blood storage duration
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2007-04-11
Enrollment: 3942
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility 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

Primary outcomes:
measure: Primary Aim is to Determine Whether Length of Storage of Red Blood Cells is Related to Postoperative Morbid Outcomes in Patients Undergoing Cardiac Surgery.
timeFrame: 30 days post surgery.
measure: Effect of RBC Age on Occurrence of Mortality or Multisystem Organ Failure Events
timeFrame: 30 days post surgery
measure: Effect of RBC Age on Occurrence of Neurologic Events
timeFrame: 30 days post surgery.
measure: Effect of RBC Age on Occurrence of Pulmonary Events.
timeFrame: 30 days post surgery.
measure: Effect of RBC Age on Occurrence of Renal Failure
timeFrame: 30 days post surgery.
measure: Effect of RBC Age on Occurrence of Infection Events
timeFrame: 30 days post surgery.
measure: Effect of RBC Age on Occurrence of Atrial Fibrillation
timeFrame: 30 days post surgery.
measure: Effect of RBC Age on Occurrence of Asystole
timeFrame: 30 days post surgery.
measure: Effect of RBC Age on Occurrence of Gastrointestinal Events
timeFrame: 30 days post surgery.
measure: Effect of RBC Age on Occurrence of Any Reoperation
timeFrame: 30 days post surgery.
measure: Effect of RBC Age on Occurrence of Vascular Events
timeFrame: 30 days post surgery.
Secondary outcomes:
measure: Effect of RBC Age on Intensive Care Unit (ICU) Length of Stay.
timeFrame: The total hours from start to end in the Intensive Care Unit (ICU).
measure: Effect of RBC Age on Postoperative Hospital Lengths of Stay.
timeFrame: The total days from start to end of the Hospital Stay.
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Andra Duncan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kekre N, Mallick R, Allan D, Tinmouth A, Tay J. The impact of prolonged storage of red blood cells on cancer survival. PLoS One. 2013 Jul 16;8(7):e68820. doi: 10.1371/journal.pone.0068820. Print 2013.