Skip to main content
OpenTrials
Completed

NCT Number: NCT05889494

Autologous Whole Blood Management for Transfusion Reduction in Adult Cardiac Surgery Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alberta

Edmonton, Alberta, T6G2G3, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult (≥18 yr)
  • Surgical patients at the Mazankowski Alberta Heart Institute
  • High risk for acquired coagulopathy

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Autologous Whole Blood Management

Other

Intraoperative high volume autologous whole blood withdrawal with re-transfusion following weaning from CPB.

Other names: Intraoperative autologous whole blood donation

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.

Primary outcomes

  1. Adequacy of recruitment.

    Time frame: 12 months.

    Proportion of screened eligible patients that are successfully recruited.

Secondary outcomes

  1. Number of allogenic units transfused.

    Time frame: 24 hours

    Number of units of red blood cell, plasma, platelets, cryoprecipitate administered intra-operatively and within the first 24hrs post-operatively.

  2. Dose of prothrombin complex concentrates.

    Time frame: 24hrs

    Dose (in units per kilogram) of prothrombin complex concentrates given intraoperatively and within the first 24 hrs postoperatively.

  3. Dose of fibrinogen.

    Time frame: 24 hrs

    Dose (grams per kilogram) of fibrinogen given intraoperatively and within the first 24 hrs postoperatively.

  4. 24-Hour chest tube output.

    Time frame: 24 hours

    Measured in millilitres during first 24 hours post-operatively.

  5. Time to extubation.

    Time frame: 30 days

    Measured in hours from time of arrival to ICU admission (index admission) until extubated.

  6. ICU length of stay.

    Time frame: 30 days

    Measured as number of days in ICU.

  7. Hospital length of stay.

    Time frame: 30 days

    Measured as number of days in hospital.

  8. Incidence of postoperative myocardial infarction (MI).

    Time frame: 30 days

    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.

  9. Incidence of infection.

    Time frame: 30 days

    Any new infection following cardiac surgery and within the first 30 days post-operatively.

  10. Incidence of post-operative stroke.

    Time frame: 30 days

    Defined as any acute onset focal neurological deficit lasting more than 24 hours that corresponded to clinical assessment and brain imaging.

  11. Incidence of acute lung injury.

    Time frame: 30 days

    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.

  12. Incidence of acute kidney injury (AKI).

    Time frame: 30 days

    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.

  13. Incidence of new requirement renal replacement therapy.

    Time frame: 30 days

    Defined as any new postoperative requirement of renal replacement therapy within the first 30 days of surgery.

  14. Incidence of new onset atrial fibrillation.

    Time frame: 30 days

    Defined as new postoperative atrial fibrillation, persistent or paroxysmal, within the first 30 days postoperative.

  15. Incidence of death within 30-days post-operatively.

    Time frame: 30 days

    Defined as death within the first 30 days postoperative.

Other outcomes

  1. Research assistant cost per participant.

    Time frame: 12 months

    Assess time required of research assistant to enroll participant and extract data variables from electronic medical record.

  2. Proportion of recruited participants successfully randomized.

    Time frame: 12 months

    Assess proportion of recruited participants that are successfully randomized with (target of >80%).

  3. Number of participants with inadvertent unblinding of the intensive care clinicians.

    Time frame: 12 months

    Assess number of participants with inadvertent unblinding of the intensive care clinicians (target of <5%).

  4. Number of major protocol deviations (adherence).

    Time frame: 12 months

    Assess number and define areas of protocol deviations.

  5. Number of participants without complete follow-up.

    Time frame: 12 months

    Assess number of participants lost to follow-up (target <10%).

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Alberta Innovates Health Solutions
  • EPICORE Centre
  • University Hospital Foundation

Registry information

Official study title

Autologous Whole Blood Management for Reduction of Blood Product Transfusion in Adult Cardiac Surgery Patients: a Local Feasibility/Pilot Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 5, 2023
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.