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

NCT05889494 | Completed DMC

• 1 other identifier: Pro00110883
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Postoperative Hemorrhage; Postoperative Anemia; Postoperative Blood Loss

Keywords

Cardiac surgery; Postoperative coagulopathy; Autologous whole blood transfusion; Acute normovolemic hemodilution; Intraoperative autologous transfusion

Outcome Measures

Primary Outcomes (1)

• Adequacy of recruitment.

  Proportion of screened eligible patients that are successfully recruited.

  12 months.

Secondary Outcomes (15)

• Number of allogenic units transfused.

  24 hours

• Dose of prothrombin complex concentrates.

  24hrs

• Dose of fibrinogen.

  24 hrs

• 24-Hour chest tube output.

  24 hours

• Time to extubation.

  30 days

Other Outcomes (5)

• Research assistant cost per participant.

  12 months

• Proportion of recruited participants successfully randomized.

  12 months

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

  12 months

Study Arms (2)

Autologous Whole Blood Management

EXPERIMENTAL

Intraoperative high volume autologous whole blood withdrawal prior to cardiopulmonary bypass (CPB) with re-transfusion following weaning from CPB.

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.

Other: Standard Care involving allogenic and/or derivative transfusion.

Interventions

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.

Allogenic and Derivative Transfusion

Autologous Whole Blood Management OTHER

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

Also known as: Intraoperative autologous whole blood donation

Autologous Whole Blood Management

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead
• University Hospital Foundation: collaborator
• Alberta Innovates Health Solutions: collaborator
• EPICORE Centre: collaborator

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G2G3, Canada

Location

MeSH Terms

Conditions

Postoperative Hemorrhage

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications

Study Officials

• Angela R Neufeld, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The participant, intensive care unit physician, and outcome assessors will be blinded to study arm. The intraoperative anesthesiologist will not be blinded to study arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: June 5, 2023
• Study Start: March 24, 2025
• Primary Completion: January 27, 2026
• Study Completion: February 26, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

CA (1)