- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00458783
Red Cell Storage Duration and Outcomes in Cardiac Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44195
- Cleveland Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
|
Transfusion with oldest available matching RBCs
|
Active Comparator: Short RBC storage
Transfusion with youngest available matching RBCs.
|
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
Sponsor
Investigators
- Principal Investigator: Andra Duncan, MD, The Cleveland Clinic
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
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.
Clinical Trials on Cardiac Surgery
-
Nationwide Children's HospitalCompleted
-
Universitätsklinikum Hamburg-EppendorfRecruitingSerratus Anterior Plane Block | Minimal Invasive Cardiac Surgery | Minimal Invasive Cardiac Surgery Mitral Valve SurgeryGermany
-
Shanghai Zhongshan HospitalRecruitingCardiac Surgery | Cardiac OutputChina
-
Sheba Medical CenterTerminatedDisorder; Heart, Functional, Postoperative, Cardiac Surgery | Heart; Dysfunction Postoperative, Cardiac SurgeryIsrael
-
McMaster UniversityCanadian Institutes of Health Research (CIHR); Population Health Research Institute and other collaboratorsActive, not recruitingSurgery (Cardiac) | Surgery (Major Vascular)Canada, United Kingdom
-
Maquet Cardiopulmonary GmbHNAMSARecruitingCardiac Surgery | Cardiopulmonary Bypass | Thoracic Surgery | Vascular SurgerySpain
-
Baylor Research InstituteChiesi USA, Inc.RecruitingSurgery | Cardiac Surgery | Surgery--Complications | Percutaneous Coronary InterventionUnited States
-
Vanderbilt UniversityEdwards LifesciencesCompletedCardiac Surgery | Thoracic Surgery | Heart Surgery | Heart Transplant
-
Yan FuxiaNot yet recruitingCardiac Surgery | Enhanced Recovery After SurgeryChina
-
Yonsei UniversityCompletedCardiac Surgery | Vascular Surgery Using CPBKorea, Republic of
Clinical Trials on Prolonged RBC storage
-
Mayo ClinicCompletedBlood Protein Disorders | Pulmonary EdemasUnited States
-
Washington University School of MedicineNational Heart, Lung, and Blood Institute (NHLBI); Canadian Institutes of Health... and other collaboratorsCompletedAnemiaUnited States, Canada, France, Israel, Italy
-
Emory UniversityTerminated
-
Fondazione Policlinico Universitario Agostino Gemelli...Fresenius HemocareRecruitingRetinopathy of PrematurityItaly
-
Daping Hospital and the Research Institute of Surgery...Children's Hospital of Chongqing Medical UniversityWithdrawnAnemia | Necrotizing Enterocolitis | Red Blood Cell (RBC) TransfusionChina
-
Ottawa Hospital Research InstituteCanadian Institutes of Health Research (CIHR); Canadian Blood ServicesActive, not recruitingRed Blood Cell TransfusionCanada
-
University of MiamiNational Heart, Lung, and Blood Institute (NHLBI)CompletedCoronary Artery BypassUnited States
-
University of EdinburghNHS Lothian; Chief Scientist Office of the Scottish Government; Transfusion Medicine...CompletedAnemia | Blood Transfusion | Intensive CareUnited Kingdom
-
Oregon Health and Science UniversityUnited States Air Force; Armed Services Blood ProgramCompleted
-
Massachusetts General HospitalCompleted