Blood TransfusionNCT00458783
Red Cell Storage Duration and Outcomes in Cardiac Surgery
A study testing Prolonged RBC storage and Short RBC storage in people with Blood Transfusion and Cardiac Surgery, run by The Cleveland Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Transfusion, Cardiac Surgery
- What is being tested?
- Prolonged RBC storage and Short RBC storage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,942 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to 16 Jan 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Age less than 18 years
- Descending thoracic aortic aneurysm repairs
- Left or right ventricular assist devices
- Those unable to receive blood for religious reasons
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Blood Transfusion, Cardiac Surgery
- Being tested
- Prolonged RBC storage, Short RBC storage
- Keywords
- Transfusion, Cardiac, Blood storage duration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged RBC storageBiological
Transfusion with oldest available matching RBCs
Short RBC storageBiological
Transfusion with youngest available matching RBCs
| Study group | Role | What they receive |
|---|---|---|
| Prolonged RBC storage | Active comparator | Transfusion with oldest available matching RBCs. Receives: Biological: Prolonged RBC storage |
| Short RBC storage | Active comparator | Transfusion with youngest available matching RBCs. Receives: Biological: Short RBC storage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days post surgery.
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.
Measured: 30 days post surgery
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.
Measured: 30 days post surgery.
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.
Measured: 30 days post surgery.
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.
Measured: 30 days post surgery.
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.
Measured: 30 days post surgery.
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.
Measured: 30 days post surgery.
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.
Measured: 30 days post surgery.
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.
Measured: 30 days post surgery.
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.
Measured: 30 days post surgery.
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.
Measured: 30 days post surgery.
Secondary outcomes (2)
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.
Measured: The total hours from start to end in the Intensive Care Unit (ICU).
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.
Measured: The total days from start to end of the Hospital Stay.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2007 (estimated)
- Study startApr 2007
- Primary completionDec 2018
- Study completion16 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood TransfusionStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 3,942 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andra Duncan, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00458783
- Sponsor's protocol ID
- 07-140
- Status last verified
- May 2021
- First submitted
- 9 Apr 2007
- Last updated
- 3 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 23874777
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Red Cell Storage Duration and Outcomes in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT00458783
- Acronym / sponsor ID
- 07-140
- Conditions
- Blood Transfusion, Cardiac Surgery
- Keywords
- Transfusion, Cardiac, Blood storage duration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,942 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Dec 2018 (actual)
- Study completion
- 16 Jan 2019 (actual)
- First posted
- 11 Apr 2007 (estimated)
- Results
- Posted 3 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prolonged RBC storage | Active comparator | Biological: Prolonged RBC storageTransfusion with oldest available matching RBCs. |
| Short RBC storage | Active comparator | Biological: Short RBC storageTransfusion with youngest available matching RBCs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (4 listed)
- Age less than 18 years
- Descending thoracic aortic aneurysm repairs
- Left or right ventricular assist devices
- Those unable to receive blood for religious reasons
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prolonged RBC storageTransfusion with oldest available matching RBCs | Biological | Prolonged RBC storage |
| Short RBC storageTransfusion with youngest available matching RBCs | Biological | Short RBC storage |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
2 secondary outcomes
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).
Effect of RBC Age on Postoperative Hospital Lengths of Stay.
Time frame: The total days from start to end of the Hospital Stay.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23874777Kekre 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andra Duncan, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolonged RBC storage and Short RBC storage in people with Blood Transfusion and Cardiac Surgery, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 30 days post surgery.). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00458783, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2021.