Postoperative HemorrhageNCT05889494
Autologous Whole Blood Management for Transfusion Reduction in Adult Cardiac Surgery Patients
A study testing Autologous Whole Blood Management in people with Postoperative Hemorrhage and Postoperative Anemia, run by University of Alberta at 1 site in Canada.
Trial summary
The goal of this pilot trial is to test a protocol for a planned Canada-wide clinical trial looking at whether or not the use of a patients own blood works as good as the current standard of care using donated blood products to reduce blood loss in adult patients having heart surgery. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Hemorrhage, Postoperative Anemia, Postoperative Blood Loss
- What is being tested?
- Autologous Whole Blood Management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteCanada
- Study dates
- 24 Mar 2025to 26 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult (≥18 yr)
- Surgical patients at the Mazankowski Alberta Heart Institute
- High risk for acquired coagulopathy
Who cannot join
- Left ventricular ejection fraction <20%
- Impaired renal function
- Preoperative anemia (hematocrit < 30%)
- Abnormal coagulation studies or platelet function
- Presence of hemoglobinopathy
- Platelet count < 120 10*9/L
Show all 17Show fewer
- Non-heparin based CPB anticoagulation
- Presence of carotid stenosis (≥70%)
- Presence of bacteremia/endocarditis
- Age > 85 yr
- Weight < 55 kg
- Hepatic failure/dysfunction
- Pregnancy
- Chronic lung disease on home O2
- Acute respiratory failure
- Acute coronary syndromes
- Emergency surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Autologous Whole Blood Management for Reduction of Blood Product Transfusion in Adult Cardiac Surgery Patients: a Local Feasibility/Pilot Study
The goal of this pilot trial is to test a protocol for a planned Canada-wide clinical trial looking at whether or not the use of a patients own blood works as good as the current standard of care using donated blood products to reduce blood loss in adult patients having heart surgery.
The main questions this study aims to answer are:
Read more
- Is the protocol practical, effective, and efficient.
- Does the use of a patients own blood lower the following: bleeding, the amount donated blood products given, and complications.
Participants will be separated into two groups by a process that is like flipping a coin. One group will donate blood to themselves in the operating room and get their own blood back after surgery. The other group will be given blood products donated by other humans to treat the bleeding after heart surgery.
Researchers will compare both groups to see if patients that get their own blood have fewer donated blood products given at time of heart surgery and have less complications after surgery.
Read the detailed description
Cardiac surgery patients are at risk for perioperative bleeding and transfusion due to the invasiveness of the surgery and an acquired coagulopathy that is unique to this sub-specialty. High transfusion rates in this population are related to surgical field blood loss and the development of a multi-factorial coagulopathy. Due to these circumstances, cardiac surgery patients account for up to 20% of total annual blood transfusion with a subset of high risk patients consuming 80% of all transfusion in this group. On this basis, employing blood conservation methods is extremely relevant as the use of donated blood products leads to greater rates of infectious complications, atrial fibrillation, prolonged postoperative ventilation, acute renal injury, and reduced short and long-term survival in cardiac surgery patients. Reducing the health and cost burden associated with transfusion is an important outcome to both the patient and health care system. Intraoperative autologous whole blood transfusion, a blood-conservation method similar to acute normovolemic hemodilution, may reduce transfusion and its associated complications but there is a paucity of large scale prospective randomized control trials investigating its efficacy in the era of modern surgical approaches, targeted transfusion using point-of-care viscoelastic testing, and advanced perfusion techniques. The intent of this study is to assess the feasibility of a trial protocol for a large-scale national study investigating high volume autologous whole blood transfusion for reduction in allogenic transfusion, derivative administration, and transfusion-associated morbidity and mortality.
- Being tested
- Autologous Whole Blood Management, Standard Care involving allogenic and/or derivative transfusion.
- Keywords
- Cardiac surgery, Postoperative coagulopathy, Autologous whole blood transfusion, Acute normovolemic hemodilution, Intraoperative autologous transfusion
- Medical subject headings
- Postoperative Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Whole Blood ManagementOther
Also called Intraoperative autologous whole blood donation
Intraoperative high volume autologous whole blood withdrawal with re-transfusion following weaning from CPB.
Standard Care involving allogenic and/or derivative transfusion.Other
Therapeutic treatment of CPB-induced coagulopathy using donated allogenic blood products including plasma, platelets, and cryoprecipitate and/or derivative administration using prothrombin complex and fibrinogen concentrates.
| Study group | Role | What they receive |
|---|---|---|
| Autologous Whole Blood Management | Experimental | Intraoperative high volume autologous whole blood withdrawal prior to cardiopulmonary bypass (CPB) with re-transfusion following weaning from CPB. Receives: Other: Autologous Whole Blood Management |
| Allogenic and Derivative Transfusion | Active comparator | Control arm participants will receive standard care involving transfusion of plasma, platelets, cryoprecipitate, and/or lyophilized concentrates following weaning from CPB. Receives: Other: Standard Care involving allogenic and/or derivative transfusion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequacy of recruitment.
Proportion of screened eligible patients that are successfully recruited.
Measured: 12 months.
Secondary outcomes (15)
Number of allogenic units transfused.
Number of units of red blood cell, plasma, platelets, cryoprecipitate administered intra-operatively and within the first 24hrs post-operatively.
Measured: 24 hours
Dose of prothrombin complex concentrates.
Dose (in units per kilogram) of prothrombin complex concentrates given intraoperatively and within the first 24 hrs postoperatively.
Measured: 24hrs
Dose of fibrinogen.
Dose (grams per kilogram) of fibrinogen given intraoperatively and within the first 24 hrs postoperatively.
Measured: 24 hrs
24-Hour chest tube output.
Measured in millilitres during first 24 hours post-operatively.
Measured: 24 hours
Time to extubation.
Measured in hours from time of arrival to ICU admission (index admission) until extubated.
Measured: 30 days
ICU length of stay.
Measured as number of days in ICU.
Measured: 30 days
Hospital length of stay.
Measured as number of days in hospital.
Measured: 30 days
Incidence of postoperative myocardial infarction (MI).
As measured by laboratory serum troponin and one or more of: new left bundle branch block, new pathological Q waves on electrocardiogram, new regional wall motion abnormality on echocardiogram, identification of intracoronary thrombus on angiography or at the time of autopsy.
Measured: 30 days
Incidence of infection.
Any new infection following cardiac surgery and within the first 30 days post-operatively.
Measured: 30 days
Incidence of post-operative stroke.
Defined as any acute onset focal neurological deficit lasting more than 24 hours that corresponded to clinical assessment and brain imaging.
Measured: 30 days
Incidence of acute lung injury.
Defined as any acute inflammation in the lung that causes disruption of the lung endothelial and epithelial barriers with partial pressure of oxygen tension in arterial blood (PaO2) to fraction inspired oxygen (FiO2) ratio of less than 300.
Measured: 30 days
Incidence of acute kidney injury (AKI).
Defined per the Kidney Disease Improving Global Outcomes (KDIGO ) criteria for Stage 2 and 3 AKI: 2.0-2.9 time postoperative increase in serum creatinine from preoperative value (stage 2); greater than 3.0 times increase in serum creatinine from preoperative value or increase in serum creatinine to greater than or equal to 353.6 micromole per litre or initiation of new renal replacement therapy postoperatively (stage 3) within 30 days.
Measured: 30 days
Incidence of new requirement renal replacement therapy.
Defined as any new postoperative requirement of renal replacement therapy within the first 30 days of surgery.
Measured: 30 days
Incidence of new onset atrial fibrillation.
Defined as new postoperative atrial fibrillation, persistent or paroxysmal, within the first 30 days postoperative.
Measured: 30 days
Incidence of death within 30-days post-operatively.
Defined as death within the first 30 days postoperative.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start24 Mar 2025
- Primary completion27 Jan 2026
- Study completion26 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative HemorrhageStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Foundation, Alberta Innovates Health Solutions, EPICORE Centre
- Responsible party
- Sponsor
- Investigators
- Angela R Neufeld, MD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05889494
- Sponsor's protocol ID
- Pro00110883
- Status last verified
- Mar 2026
- First submitted
- 4 May 2023
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Whole Blood Management for Reduction of Blood Product Transfusion in Adult Cardiac Surgery Patients: a Local Feasibility/Pilot Study
- ClinicalTrials.gov ID
- NCT05889494
- Acronym / sponsor ID
- Pro00110883
- Keywords
- Cardiac surgery, Postoperative coagulopathy, Autologous whole blood transfusion, Acute normovolemic hemodilution, Intraoperative autologous transfusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- University Hospital Foundation, Alberta Innovates Health Solutions, EPICORE Centre
- Study start
- 24 Mar 2025 (actual)
- Primary completion
- 27 Jan 2026 (actual)
- Study completion
- 26 Feb 2026 (actual)
- First posted
- 5 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this pilot trial is to test a protocol for a planned Canada-wide clinical trial looking at whether or not the use of a patients own blood works as good as the current standard of care using donated blood products to reduce blood loss in adult patients having heart surgery.
The main questions this study aims to answer are:
- Is the protocol practical, effective, and efficient.
- Does the use of a patients own blood lower the following: bleeding, the amount donated blood products given, and complications.
Participants will be separated into two groups by a process that is like flipping a coin. One group will donate blood to themselves in the operating room and get their own blood back after surgery. The other group will be given blood products donated by other humans to treat the bleeding after heart surgery.
Researchers will compare both groups to see if patients that get their own blood have fewer donated blood products given at time of heart surgery and have less complications after surgery.
Detailed description
Cardiac surgery patients are at risk for perioperative bleeding and transfusion due to the invasiveness of the surgery and an acquired coagulopathy that is unique to this sub-specialty. High transfusion rates in this population are related to surgical field blood loss and the development of a multi-factorial coagulopathy. Due to these circumstances, cardiac surgery patients account for up to 20% of total annual blood transfusion with a subset of high risk patients consuming 80% of all transfusion in this group. On this basis, employing blood conservation methods is extremely relevant as the use of donated blood products leads to greater rates of infectious complications, atrial fibrillation, prolonged postoperative ventilation, acute renal injury, and reduced short and long-term survival in cardiac surgery patients. Reducing the health and cost burden associated with transfusion is an important outcome to both the patient and health care system. Intraoperative autologous whole blood transfusion, a blood-conservation method similar to acute normovolemic hemodilution, may reduce transfusion and its associated complications but there is a paucity of large scale prospective randomized control trials investigating its efficacy in the era of modern surgical approaches, targeted transfusion using point-of-care viscoelastic testing, and advanced perfusion techniques. The intent of this study is to assess the feasibility of a trial protocol for a large-scale national study investigating high volume autologous whole blood transfusion for reduction in allogenic transfusion, derivative administration, and transfusion-associated morbidity and mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autologous Whole Blood Management | Experimental | Other: Autologous Whole Blood ManagementIntraoperative high volume autologous whole blood withdrawal prior to cardiopulmonary bypass (CPB) with re-transfusion following weaning from CPB. |
| Allogenic and Derivative Transfusion | Active comparator | Other: Standard Care involving allogenic and/or derivative transfusion.Control arm participants will receive standard care involving transfusion of plasma, platelets, cryoprecipitate, and/or lyophilized concentrates following weaning from CPB. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult (≥18 yr)
- Surgical patients at the Mazankowski Alberta Heart Institute
- High risk for acquired coagulopathy
Key exclusion criteria (17 listed)
- Left ventricular ejection fraction <20%
- Impaired renal function
- Preoperative anemia (hematocrit < 30%)
- Abnormal coagulation studies or platelet function
- Presence of hemoglobinopathy
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 |
|---|---|---|
| Autologous Whole Blood ManagementAlso: Intraoperative autologous whole blood donationIntraoperative high volume autologous whole blood withdrawal with re-transfusion following weaning from CPB. | Other | Autologous Whole Blood Management |
| Standard Care involving allogenic and/or derivative transfusion.Therapeutic treatment of CPB-induced coagulopathy using donated allogenic blood products including plasma, platelets, and cryoprecipitate and/or derivative administration using prothrombin complex and fibrinogen concentrates. | Other | Allogenic and Derivative Transfusion |
Primary outcome
Adequacy of recruitment.
Time frame: 12 months.
Proportion of screened eligible patients that are successfully recruited.
15 secondary outcomes
Number of allogenic units transfused.
Time frame: 24 hours
Dose of prothrombin complex concentrates.
Time frame: 24hrs
Dose of fibrinogen.
Time frame: 24 hrs
24-Hour chest tube output.
Time frame: 24 hours
Time to extubation.
Time frame: 30 days
ICU length of stay.
Time frame: 30 days
Hospital length of stay.
Time frame: 30 days
Incidence of postoperative myocardial infarction (MI).
Time frame: 30 days
Incidence of infection.
Time frame: 30 days
Incidence of post-operative stroke.
Time frame: 30 days
Incidence of acute lung injury.
Time frame: 30 days
Incidence of acute kidney injury (AKI).
Time frame: 30 days
Incidence of new requirement renal replacement therapy.
Time frame: 30 days
Incidence of new onset atrial fibrillation.
Time frame: 30 days
Incidence of death within 30-days post-operatively.
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
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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.
Angela R Neufeld, MD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous Whole Blood Management in people with Postoperative Hemorrhage and Postoperative Anemia, run by University of Alberta at 1 site in Canada.
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 3 inclusion and 17 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 18 Mar 2026. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adequacy of recruitment. (time frame: 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Mar 2026.