Clinical trial NCT05889494: Autologous Whole Blood Management for Transfusion Reduction in Adult Cardiac Surgery Patients
Official title: Autologous Whole Blood Management for Reduction of Blood Product Transfusion in Adult Cardiac Surgery Patients: a Local Feasibility/Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postoperative Hemorrhage
Postoperative Anemia
Postoperative Blood Loss
Keywords: Cardiac surgery
Postoperative coagulopathy
Autologous whole blood transfusion
Acute normovolemic hemodilution
Intraoperative autologous transfusion
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: University Hospital Foundation
name: Alberta Innovates Health Solutions
name: EPICORE Centre
First posted: 2023-06-05
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Adequacy of recruitment.
timeFrame: 12 months.
Secondary outcomes:
measure: Number of allogenic units transfused.
timeFrame: 24 hours
measure: Dose of prothrombin complex concentrates.
timeFrame: 24hrs
measure: Dose of fibrinogen.
timeFrame: 24 hrs
measure: 24-Hour chest tube output.
timeFrame: 24 hours
measure: Time to extubation.
timeFrame: 30 days
measure: ICU length of stay.
timeFrame: 30 days
measure: Hospital length of stay.
timeFrame: 30 days
measure: Incidence of postoperative myocardial infarction (MI).
timeFrame: 30 days
measure: Incidence of infection.
timeFrame: 30 days
measure: Incidence of post-operative stroke.
timeFrame: 30 days
measure: Incidence of acute lung injury.
timeFrame: 30 days
measure: Incidence of acute kidney injury (AKI).
timeFrame: 30 days
measure: Incidence of new requirement renal replacement therapy.
timeFrame: 30 days
measure: Incidence of new onset atrial fibrillation.
timeFrame: 30 days
measure: Incidence of death within 30-days post-operatively.
timeFrame: 30 days
Other outcomes:
measure: Research assistant cost per participant.
timeFrame: 12 months
measure: Proportion of recruited participants successfully randomized.
timeFrame: 12 months
measure: Number of participants with inadvertent unblinding of the intensive care clinicians.
timeFrame: 12 months
measure: Number of major protocol deviations (adherence).
timeFrame: 12 months
measure: Number of participants without complete follow-up.
timeFrame: 12 months
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Angela R Neufeld, MD
role: PRINCIPAL_INVESTIGATOR
References: