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

Primary Purpose

Postoperative Hemorrhage, Postoperative Anemia, Postoperative Blood Loss

Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Autologous Whole Blood Management
Standard Care involving allogenic and/or derivative transfusion.
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Hemorrhage focused on measuring Cardiac surgery, Postoperative coagulopathy, Autologous whole blood transfusion, Acute normovolemic hemodilution, Intraoperative autologous transfusion

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Alberta

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Autologous Whole Blood Management

Allogenic and Derivative Transfusion

Arm Description

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

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

Outcomes

Primary Outcome Measures

Adequacy of recruitment.
Proportion of screened eligible patients that are successfully recruited.

Secondary Outcome Measures

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.
Dose of prothrombin complex concentrates.
Dose (in units per kilogram) of prothrombin complex concentrates given intraoperatively and within the first 24 hrs postoperatively.
Dose of fibrinogen.
Dose (grams per kilogram) of fibrinogen given intraoperatively and within the first 24 hrs postoperatively.
24-Hour chest tube output.
Measured in millilitres during first 24 hours post-operatively.
Time to extubation.
Measured in hours from time of arrival to ICU admission (index admission) until extubated.
ICU length of stay.
Measured as number of days in ICU.
Hospital length of stay.
Measured as number of days in hospital.
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.
Incidence of infection.
Any new infection following cardiac surgery and within the first 30 days post-operatively.
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.
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.
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.
Incidence of new requirement renal replacement therapy.
Defined as any new postoperative requirement of renal replacement therapy within the first 30 days of surgery.
Incidence of new onset atrial fibrillation.
Defined as new postoperative atrial fibrillation, persistent or paroxysmal, within the first 30 days postoperative.
Incidence of death within 30-days post-operatively.
Defined as death within the first 30 days postoperative.

Full Information

First Posted
May 4, 2023
Last Updated
October 16, 2023
Sponsor
University of Alberta
Collaborators
University Hospital Foundation, Alberta Innovates Health Solutions, EPICORE Centre
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1. Study Identification

Unique Protocol Identification Number
NCT05889494
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
Collaborators
University Hospital Foundation, Alberta Innovates Health Solutions, EPICORE Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Hemorrhage, Postoperative Anemia, Postoperative Blood Loss
Keywords
Cardiac surgery, Postoperative coagulopathy, Autologous whole blood transfusion, Acute normovolemic hemodilution, Intraoperative autologous transfusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Autologous Whole Blood Management
Arm Type
Experimental
Arm Description
Intraoperative high volume autologous whole blood withdrawal prior to cardiopulmonary bypass (CPB) with re-transfusion following weaning from CPB.
Arm Title
Allogenic and Derivative Transfusion
Arm Type
Active Comparator
Arm Description
Control arm participants will receive standard care involving transfusion of plasma, platelets, cryoprecipitate, and/or lyophilized concentrates following weaning from CPB.
Intervention Type
Other
Intervention Name(s)
Autologous Whole Blood Management
Other Intervention Name(s)
Intraoperative autologous whole blood donation
Intervention Description
Intraoperative high volume autologous whole blood withdrawal with re-transfusion following weaning from CPB.
Intervention Type
Other
Intervention Name(s)
Standard Care involving allogenic and/or derivative transfusion.
Intervention Description
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 Outcome Measure Information:
Title
Adequacy of recruitment.
Description
Proportion of screened eligible patients that are successfully recruited.
Time Frame
12 months.
Secondary Outcome Measure Information:
Title
Number of allogenic units transfused.
Description
Number of units of red blood cell, plasma, platelets, cryoprecipitate administered intra-operatively and within the first 24hrs post-operatively.
Time Frame
24 hours
Title
Dose of prothrombin complex concentrates.
Description
Dose (in units per kilogram) of prothrombin complex concentrates given intraoperatively and within the first 24 hrs postoperatively.
Time Frame
24hrs
Title
Dose of fibrinogen.
Description
Dose (grams per kilogram) of fibrinogen given intraoperatively and within the first 24 hrs postoperatively.
Time Frame
24 hrs
Title
24-Hour chest tube output.
Description
Measured in millilitres during first 24 hours post-operatively.
Time Frame
24 hours
Title
Time to extubation.
Description
Measured in hours from time of arrival to ICU admission (index admission) until extubated.
Time Frame
30 days
Title
ICU length of stay.
Description
Measured as number of days in ICU.
Time Frame
30 days
Title
Hospital length of stay.
Description
Measured as number of days in hospital.
Time Frame
30 days
Title
Incidence of postoperative myocardial infarction (MI).
Description
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.
Time Frame
30 days
Title
Incidence of infection.
Description
Any new infection following cardiac surgery and within the first 30 days post-operatively.
Time Frame
30 days
Title
Incidence of post-operative stroke.
Description
Defined as any acute onset focal neurological deficit lasting more than 24 hours that corresponded to clinical assessment and brain imaging.
Time Frame
30 days
Title
Incidence of acute lung injury.
Description
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.
Time Frame
30 days
Title
Incidence of acute kidney injury (AKI).
Description
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.
Time Frame
30 days
Title
Incidence of new requirement renal replacement therapy.
Description
Defined as any new postoperative requirement of renal replacement therapy within the first 30 days of surgery.
Time Frame
30 days
Title
Incidence of new onset atrial fibrillation.
Description
Defined as new postoperative atrial fibrillation, persistent or paroxysmal, within the first 30 days postoperative.
Time Frame
30 days
Title
Incidence of death within 30-days post-operatively.
Description
Defined as death within the first 30 days postoperative.
Time Frame
30 days
Other Pre-specified Outcome Measures:
Title
Research assistant cost per participant.
Description
Assess time required of research assistant to enroll participant and extract data variables from electronic medical record.
Time Frame
12 months
Title
Proportion of recruited participants successfully randomized.
Description
Assess proportion of recruited participants that are successfully randomized with (target of >80%).
Time Frame
12 months
Title
Number of participants with inadvertent unblinding of the intensive care clinicians.
Description
Assess number of participants with inadvertent unblinding of the intensive care clinicians (target of <5%).
Time Frame
12 months
Title
Number of major protocol deviations (adherence).
Description
Assess number and define areas of protocol deviations.
Time Frame
12 months
Title
Number of participants without complete follow-up.
Description
Assess number of participants lost to follow-up (target <10%).
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Angela R Neufeld, MD
Phone
(780) 407-8861
Email
angela.neufeld@ualberta.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angela R Neufeld, MD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G2G3
Country
Canada

12. IPD Sharing Statement

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

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