Fresh Autologous Whole Blood Transfusion After Cardiopulmonary Bypass
Primary Purpose
Cardiac Disease, Bleeding Postoperative
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fresh Autologous whole Blood
Standard of Care Expectant management of bleeding
Sponsored by
About this trial
This is an interventional treatment trial for Cardiac Disease focused on measuring Cardiac surgery
Eligibility Criteria
Inclusion Criteria:
- Adult subjects aged 18 to 90
- Able to provide informed consent
- Willing to accept autologous or allogenic blood transfusion
- Scheduled for elective cardiac surgery with cardiopulmonary bypass
Exclusion Criteria:
- Pre-operative administration of allogenic blood bank products in the previous 3 months
- Hemodynamically unstable defined as a systolic blood pressure less than 90 mmHg with a heart rate greater 100 or requiring intravenous vasopressor medications
- Significant active infection or sepsis defined by positive blood culture or positive wound culture
- Hemoglobin less than 7 g/dl
Sites / Locations
- University of Colorado HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Fresh Autologous whole blood transfusion
Standard of Care Expectant Management of bleeding
Arm Description
The experimental group will have 15% of the estimated blood volume of autologous blood collected. This transfusion will be given at the end of the procedure.
the control group that will receive the standard of care expectant management of bleeding and transfusion of allogenic banked blood products
Outcomes
Primary Outcome Measures
Estimated Blood Loss
Blood loss is estimated as a percent of total estimated blood volume in the first 24 hours after cardiac surgery.
Secondary Outcome Measures
Number of allogenic transfusions given
Allogenic blood product transfusion requirements
Severity of peri-operative stroke
The severity of peri-operative stroke will be measured by the National institute of health stroke scale
Incident of peri-operative stroke
The incident of peri-operative stroke will be measured by the National institute of health stroke scale
Development of Post-operative delirium
Measured by Confusion Assessment Method - Intensive Care Unit
Development of Myocardial Infarction
As measured by physiological parameters
Development of Heart failure
As measured by physiological parameters
Detection of New Onset Atrial fibrillation
As measured by an electrocardiogram
Development of Lung injury
Measured by a Pa02/Fi02 ratio
Time to extubation
Time from when the breathing tube was placed to the time when the breathing tube is removed
Development of Acute Kidney Injury
As measured by abnormal lab values
Initiation of renal replacement therapy
Time to start of renal replacement therapy
ICU length of stay
This will be measured by the number of days in ICU
Evaluation of Vasopressor requirements (1)
Measurement of the amount of vasopressors given
Evaluation of Vasopressor requirements (2)
Measurement of the types of vasopressors given
Change in endothelial function measured by flow mediated dilation of the brachial artery
Measurement of brachial artery dilation in response to flow by ultrasonography
Full Information
NCT ID
NCT03204357
First Posted
June 27, 2017
Last Updated
February 14, 2023
Sponsor
University of Colorado, Denver
1. Study Identification
Unique Protocol Identification Number
NCT03204357
Brief Title
Fresh Autologous Whole Blood Transfusion After Cardiopulmonary Bypass
Official Title
Targeted Fresh Autologous Whole Blood Transfusion After Cardiopulmonary Bypass: a Prospective Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 24, 2022 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Autologous blood transfused at the end of cardiopulmonary bypass will reduce total blood loss 24 hours after surgery and improve mitochondrial oxygen delivery measured by plasma succinate levels.
The study design is a prospective randomized interventional trial of transfusion of fresh autologous whole blood versus standard of care expectant management of bleeding during elective cardiac surgery.
Detailed Description
Cardiac surgery carries a significant risk of bleeding requiring transfusion of stored blood products and blood transfusion associated with cardiac surgery consumes 20% of the blood supply worldwide. Although transfusion may be life-saving, significant risks of complications such as lung injury or even an increase in mortality are associated with transfusion. Decreasing transfusion requirements during cardiac surgery has the potential to reduce the rate of complications, improve patient outcomes, and reduce cost resulting in increased value for both the patient and the health system as a whole. Collection of autologous blood before cardiopulmonary bypass (CPB) for transfusion after CPB has been shown to be both safe and effective for reducing blood loss during cardiac surgery, but this intervention has not been targeted to a patient population at high risk for bleeding and transfusion. Fresh whole blood has the capacity to restore coagulation system function during profound coagulopathy in a trauma setting or following massive transfusion by an unknown mechanism. One unit of fresh whole blood is able to restore clotting function equivalent to that achieved by 10 units of pooled platelets. Autologous whole blood collection prior to CPB for transfusion post-operatively has been shown to improve coagulation and decrease clot lysis but is not routinely performed because 90% to 95% of patients do not have extensive blood loss and subsequent coagulopathy. Coupling accurate pre-operative bleeding risk prediction with autologous fresh whole blood collection for transfusion after CPB would target an established, low cost, low risk intervention to an at risk patient population who may experience significant benefit.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Disease, Bleeding Postoperative
Keywords
Cardiac surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study design is a prospective randomized interventional trial of transfusion of fresh autologous whole blood versus standard of care expectant management of bleeding during elective cardiac surgery.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fresh Autologous whole blood transfusion
Arm Type
Experimental
Arm Description
The experimental group will have 15% of the estimated blood volume of autologous blood collected. This transfusion will be given at the end of the procedure.
Arm Title
Standard of Care Expectant Management of bleeding
Arm Type
Active Comparator
Arm Description
the control group that will receive the standard of care expectant management of bleeding and transfusion of allogenic banked blood products
Intervention Type
Other
Intervention Name(s)
Fresh Autologous whole Blood
Intervention Description
Subjects randomized this arm will receive fresh autologous whole blood
Intervention Type
Other
Intervention Name(s)
Standard of Care Expectant management of bleeding
Intervention Description
the control group that will receive the standard of care expectant management of bleeding and transfusion of allogenic banked blood products
Primary Outcome Measure Information:
Title
Estimated Blood Loss
Description
Blood loss is estimated as a percent of total estimated blood volume in the first 24 hours after cardiac surgery.
Time Frame
Within 24 hours after surgery
Secondary Outcome Measure Information:
Title
Number of allogenic transfusions given
Description
Allogenic blood product transfusion requirements
Time Frame
31 days
Title
Severity of peri-operative stroke
Description
The severity of peri-operative stroke will be measured by the National institute of health stroke scale
Time Frame
31 days
Title
Incident of peri-operative stroke
Description
The incident of peri-operative stroke will be measured by the National institute of health stroke scale
Time Frame
31 days
Title
Development of Post-operative delirium
Description
Measured by Confusion Assessment Method - Intensive Care Unit
Time Frame
31 days
Title
Development of Myocardial Infarction
Description
As measured by physiological parameters
Time Frame
31 days
Title
Development of Heart failure
Description
As measured by physiological parameters
Time Frame
31 days
Title
Detection of New Onset Atrial fibrillation
Description
As measured by an electrocardiogram
Time Frame
31 days
Title
Development of Lung injury
Description
Measured by a Pa02/Fi02 ratio
Time Frame
31 days
Title
Time to extubation
Description
Time from when the breathing tube was placed to the time when the breathing tube is removed
Time Frame
31 days
Title
Development of Acute Kidney Injury
Description
As measured by abnormal lab values
Time Frame
31 days
Title
Initiation of renal replacement therapy
Description
Time to start of renal replacement therapy
Time Frame
31 days
Title
ICU length of stay
Description
This will be measured by the number of days in ICU
Time Frame
31 days
Title
Evaluation of Vasopressor requirements (1)
Description
Measurement of the amount of vasopressors given
Time Frame
31 days
Title
Evaluation of Vasopressor requirements (2)
Description
Measurement of the types of vasopressors given
Time Frame
31 days
Title
Change in endothelial function measured by flow mediated dilation of the brachial artery
Description
Measurement of brachial artery dilation in response to flow by ultrasonography
Time Frame
24 hours after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult subjects aged 18 to 90
Able to provide informed consent
Willing to accept autologous or allogenic blood transfusion
Scheduled for elective cardiac surgery with cardiopulmonary bypass
Exclusion Criteria:
Pre-operative administration of allogenic blood bank products in the previous 3 months
Hemodynamically unstable defined as a systolic blood pressure less than 90 mmHg with a heart rate greater 100 or requiring intravenous vasopressor medications
Significant active infection or sepsis defined by positive blood culture or positive wound culture
Hemoglobin less than 7 g/dl
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nathan J Clendenen, M.D.
Phone
720-848-6709
Email
nathan.clendenen@cuanschutz.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Nick Naughton, B.A
Phone
720-848-6709
Email
nick.naughton@cuanschutz.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathan Clendenen, M.D.
Organizational Affiliation
University of Colorado - School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nathan Clendenen, MD MS
First Name & Middle Initial & Last Name & Degree
Nathan J Clendenen, MD MS
12. IPD Sharing Statement
Plan to Share IPD
No
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Fresh Autologous Whole Blood Transfusion After Cardiopulmonary Bypass
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