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

NCT ID: NCT05889494

Last Updated: 2025-03-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-05
• Study Completion Date: 2026-06-30

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.

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.

Conditions

Postoperative Hemorrhage; Postoperative Anemia; Postoperative Blood Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Autologous Whole Blood Management

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

Group Type: EXPERIMENTAL

Autologous Whole Blood Management

Intervention Type: OTHER

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

Allogenic and Derivative Transfusion

Control arm participants will receive standard care involving transfusion of plasma, platelets, cryoprecipitate, and/or lyophilized concentrates following weaning from CPB.

Group Type: ACTIVE_COMPARATOR

Standard Care involving allogenic and/or derivative transfusion.

Intervention Type: 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.

Interventions

Autologous Whole Blood Management

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

Intervention Type: OTHER

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.

Intervention Type: OTHER

Other Intervention Names

Intraoperative autologous whole blood donation

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital Foundation

OTHER

Sponsor Role: collaborator

Alberta Innovates Health Solutions

OTHER

Sponsor Role: collaborator

EPICORE Centre

UNKNOWN

Sponsor Role: collaborator

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Angela R Neufeld, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

University of Alberta

Edmonton, Alberta, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Angela R Neufeld, MD

Role: CONTACT

angela.neufeld@ualberta.ca

(780) 407-8861

Facility Contacts

Angela R Neufeld, MD

Role: primary

780-407-8861

Role: backup

angela.neufeld@ualberta.ca

Other Identifiers

Pro00110883

Identifier Type: -

Identifier Source: org_study_id