AnemiaNCT00651573
Balancing Risk: Red Blood Cell Transfusion Strategies In Cardiac Surgery
A study testing Blood transfusion at hematocrit value less than 24% and Blood transfusion at hematocrit value less than 28% in people with Anemia, run by The Cleveland Clinic at 2 sites in 2 countries.
Trial summary
The primary purpose of this study is to determine the best blood level to begin transfusing red blood cells in individuals undergoing cardiac surgery. The secondary aim is to determine the impact of red cell transfusion on health-related quality of life following surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia
- What is being tested?
- Blood transfusion at hematocrit value less than 24% and Blood transfusion at hematocrit value less than 28%
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 722 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Mar 2007to 3 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 and ascending aortic repair for aneurysm or dissection procedures.
Who cannot join
- Age less than 18 years
- Congenital procedures
- Emergencies
- descending thoracic aortic aneurysm repairs
- Left or right ventricular assist devices
- Left ventricular aneurysm resections
- Heart or lung transplantation
- Those unable to receive blood for religious reasons
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
The primary purpose of this study is to determine the best blood level to begin transfusing red blood cells in individuals undergoing cardiac surgery.
The secondary aim is to determine the impact of red cell transfusion on health-related quality of life following surgery.
Read the detailed description
Consecutive consenting patients who meet the inclusion criteria will be randomized to one of 2 transfusion groups based on their HCT value.
Hematocrit Groups:
- 24%
- 28%
Red blood cell transfusion will be given only when hematocrit values fall below the assigned group value. When the hematocrit value falls to a value less than the value for the randomized group a 1 unit RBC transfusion will be administered. Following administration of the 1 unit transfusion a repeat HCT is performed; if the hematocrit value responds to transfusion and is greater than or equal to the randomized group no further transfusions will be administered. A measurement of the patient's HCT after each unit of RBC administered is required prior to administering additional units. If a patient's hematocrit is greater than the value for the group which they are randomized, no transfusion of RBC is necessary. Other management decisions are left up to the discretion of the care team. Adherence to the treatment protocol will be required for the patients in the operating room, intensive care unit and postoperatively until discharge from the hospital.
Before surgery, the patient will be asked to respond to a quality-of-life questionnaire. Follow up phone calls will be made by Study personnel at 1 and 3 months after surgery to ask the same questions.
- Conditions
- Anemia
- Being tested
- Blood transfusion at hematocrit value less than 24%, Blood transfusion at hematocrit value less than 28%
- Keywords
- Surgery, Cardiopulmonary bypass, Coronary artery bypass graft, Valve procedure, Hematocrit level, Outcomes
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood transfusion at hematocrit value less than 24%Procedure or surgery
transfusion
Blood transfusion at hematocrit value less than 28%Procedure or surgery
transfusion
| Study group | Role | What they receive |
|---|---|---|
| Blood transfusion triggers of 24% hematocrit value | Active comparator | Red blood cell transfusion will be given when hematocrit values fall below the assigned group 1 value which is 24%. When the hematocrit value falls to less 24%, a 1 unit RBC transfusion will be administered. Following administration of the 1 unit transfusion a repeat HCT is performed; if the hematocrit value responds to transfusion and is greater than or equal to 24%, no further transfusions will be administered. Receives: Procedure: Blood transfusion at hematocrit value less than 24% |
| Blood transfusion triggers of 28% hematocrit value | Active comparator | Red blood cell transfusion will be given when hematocrit values fall below the assigned group 1 value which is 28%. When the hematocrit value falls to less 28%, a 1 unit RBC transfusion will be administered. Following administration of the 1 unit transfusion a repeat HCT is performed; if the hematocrit value responds to transfusion and is greater than or equal to 28%, no further transfusions will be administered. Receives: Procedure: Blood transfusion at hematocrit value less than 28% |
What is being measured
The primary outcome is the main question the study is designed to answer.
A Composite of In-hospital Postoperative Morbidity and Mortality
The composite components were in-hospital mortality, neurologic morbidity (stroke or coma), pulmonary morbidity (pneumonia, pulmonary embolus, or prolonged postoperative ventilation [>24 hours]), renal morbidity (renal failure), infectious morbidity (deep sternal wound infection, septicemia, or sepsis), cardiac arrhythmia (atrial fibrillation, ventricular tachycardia, fibrillation, or asystole), gastrointestinal morbidity, reoperation (for bleeding, tamponade, graft occlusion, valve dysfunction, or noncardiac reasons), and vascular morbidity (aortic or femoral artery dissection or acute limb ischemia).
Measured: After surgery until hosptal discharge
Secondary outcomes (5)
Length of ICU Stays
Measured: After surgery until discharged from ICU
Length of Hospital Stay
Measured: After surgery until hospital discharge
Number of Blood Transfusion
Measured: From induction to the end of sugery
Prolonged Postoperative Ventilation
On ventilation >24 hours after surgery
Measured: After surgeyr until hospital discharge
Postoperative Atrial Fibrillation
Measured: After surgery until hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2008 (estimated)
- Study startMar 2007
- Primary completionAug 2014
- Study completion3 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 (2)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies 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
- 722 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel I Sessler, MD, Study chair, The Cleveland ClinicDaniel I Sessler, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00651573
- Sponsor's protocol ID
- 08-064
- Status last verified
- Mar 2019
- First submitted
- 31 Mar 2008
- Last updated
- 14 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Carson JL, Stanworth SJ, Dennis JA, Fergusson DA, Pagano MB, Roubinian NH, Turgeon AF, Valentine S, Trivella M, Doree C, Hebert PC. Transfusion thresholds and other strategies for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2025 Oct 20;10(10):CD002042. doi: 10.1002/14651858.CD002042.pub6.
PubMed 41114449Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Doree C, Hebert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002042. doi: 10.1002/14651858.CD002042.pub5.
PubMed 34932836
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balancing Risk: Red Blood Cell Transfusion Strategies In Cardiac Surgery
- ClinicalTrials.gov ID
- NCT00651573
- Acronym / sponsor ID
- 08-064
- Conditions
- Anemia
- Keywords
- Surgery, Cardiopulmonary bypass, Coronary artery bypass graft, Valve procedure, Hematocrit level, Outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 722 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Aug 2014 (actual)
- Study completion
- 3 Jan 2019 (actual)
- First posted
- 3 Apr 2008 (estimated)
- Results
- Posted 14 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to determine the best blood level to begin transfusing red blood cells in individuals undergoing cardiac surgery.
The secondary aim is to determine the impact of red cell transfusion on health-related quality of life following surgery.
Detailed description
Consecutive consenting patients who meet the inclusion criteria will be randomized to one of 2 transfusion groups based on their HCT value.
Hematocrit Groups:
- 24%
- 28%
Red blood cell transfusion will be given only when hematocrit values fall below the assigned group value. When the hematocrit value falls to a value less than the value for the randomized group a 1 unit RBC transfusion will be administered. Following administration of the 1 unit transfusion a repeat HCT is performed; if the hematocrit value responds to transfusion and is greater than or equal to the randomized group no further transfusions will be administered. A measurement of the patient's HCT after each unit of RBC administered is required prior to administering additional units. If a patient's hematocrit is greater than the value for the group which they are randomized, no transfusion of RBC is necessary. Other management decisions are left up to the discretion of the care team. Adherence to the treatment protocol will be required for the patients in the operating room, intensive care unit and postoperatively until discharge from the hospital.
Before surgery, the patient will be asked to respond to a quality-of-life questionnaire. Follow up phone calls will be made by Study personnel at 1 and 3 months after surgery to ask the same questions.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blood transfusion triggers of 24% hematocrit value | Active comparator | Procedure: Blood transfusion at hematocrit value less than 24%Red blood cell transfusion will be given when hematocrit values fall below the assigned group 1 value which is 24%. When the hematocrit value falls to less 24%, a 1 unit RBC transfusion will be administered. Following administration of the 1 unit transfusion a repeat HCT is performed; if the hematocrit value responds to transfusion and is greater than or equal to 24%, no further transfusions will be administered. |
| Blood transfusion triggers of 28% hematocrit value | Active comparator | Procedure: Blood transfusion at hematocrit value less than 28%Red blood cell transfusion will be given when hematocrit values fall below the assigned group 1 value which is 28%. When the hematocrit value falls to less 28%, a 1 unit RBC transfusion will be administered. Following administration of the 1 unit transfusion a repeat HCT is performed; if the hematocrit value responds to transfusion and is greater than or equal to 28%, no further transfusions will be administered. |
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 and ascending aortic repair for aneurysm or dissection procedures.
Key exclusion criteria (8 listed)
- Age less than 18 years
- Congenital procedures
- Emergencies
- descending thoracic aortic aneurysm repairs
- Left or right ventricular assist devices
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 |
|---|---|---|
| Blood transfusion at hematocrit value less than 24%transfusion | Procedure or surgery | Blood transfusion triggers of 24% hematocrit value |
| Blood transfusion at hematocrit value less than 28%transfusion | Procedure or surgery | Blood transfusion triggers of 28% hematocrit value |
Primary outcome
A Composite of In-hospital Postoperative Morbidity and Mortality
Time frame: After surgery until hosptal discharge
The composite components were in-hospital mortality, neurologic morbidity (stroke or coma), pulmonary morbidity (pneumonia, pulmonary embolus, or prolonged postoperative ventilation [>24 hours]), renal morbidity (renal failure), infectious morbidity (deep sternal wound infection, septicemia, or sepsis), cardiac arrhythmia (atrial fibrillation, ventricular tachycardia, fibrillation, or asystole), gastrointestinal morbidity, reoperation (for bleeding, tamponade, graft occlusion, valve dysfunction, or noncardiac reasons), and vascular morbidity (aortic or femoral artery dissection or acute limb ischemia).
5 secondary outcomes
Length of ICU Stays
Time frame: After surgery until discharged from ICU
Length of Hospital Stay
Time frame: After surgery until hospital discharge
Number of Blood Transfusion
Time frame: From induction to the end of sugery
Prolonged Postoperative Ventilation
Time frame: After surgeyr until hospital discharge
Postoperative Atrial Fibrillation
Time frame: After surgery until hospital discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41114449Carson JL, Stanworth SJ, Dennis JA, Fergusson DA, Pagano MB, Roubinian NH, Turgeon AF, Valentine S, Trivella M, Doree C, Hebert PC. Transfusion thresholds and other strategies for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2025 Oct 20;10(10):CD002042. doi: 10.1002/14651858.CD002042.pub6.
- Derived from this study: PubMed 34932836Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Doree C, Hebert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002042. doi: 10.1002/14651858.CD002042.pub5.
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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.
Daniel I Sessler, MD study chair
The Cleveland Clinic
Daniel I Sessler, MD principal investigator
The Cleveland Clinic
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood transfusion at hematocrit value less than 24% and Blood transfusion at hematocrit value less than 28% in people with Anemia, run by The Cleveland Clinic at 2 sites in 2 countries.
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 8 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 14 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, India. 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 14 Jun 2019). 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?
A Composite of In-hospital Postoperative Morbidity and Mortality (time frame: After surgery until hosptal discharge). 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 NCT00651573, which also lists 2 linked publications.
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 14 Jun 2019.