Fresh Autologous Whole Blood Transfusion After Cardiopulmonary Bypass

Study Overview
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Brief Summary
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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
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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.

Official Title
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Targeted Fresh Autologous Whole Blood Transfusion After Cardiopulmonary Bypass: a Prospective Randomized Controlled Trial.

Conditions
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Cardiac Disease, Bleeding Postoperative

Intervention / Treatment
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* Other: Fresh Autologous whole Blood
* Other: Standard of Care Expectant management of bleeding


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fresh Autologous whole blood transfusion<br>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. | Other: Fresh Autologous whole Blood<br>* Subjects randomized this arm will receive fresh autologous whole blood<br>|
| Active Comparator: Standard of Care Expectant Management of bleeding<br>the control group that will receive the standard of care expectant management of bleeding and transfusion of allogenic banked blood products | Other: Standard of Care Expectant management of bleeding<br>* the control group that will receive the standard of care expectant management of bleeding and transfusion of allogenic banked blood products<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimated Blood Loss | Blood loss is estimated as a percent of total estimated blood volume in the first 24 hours after cardiac surgery. | Within 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of allogenic transfusions given | Allogenic blood product transfusion requirements | 31 days | 
| Severity of peri-operative stroke | The severity of peri-operative stroke will be measured by the National institute of health stroke scale | 31 days | 
| Incident of peri-operative stroke | The incident of peri-operative stroke will be measured by the National institute of health stroke scale | 31 days | 
| Development of Post-operative delirium | Measured by Confusion Assessment Method - Intensive Care Unit | 31 days | 
| Development of Myocardial Infarction | As measured by physiological parameters | 31 days | 
| Development of Heart failure | As measured by physiological parameters | 31 days | 
| Detection of New Onset Atrial fibrillation | As measured by an electrocardiogram | 31 days | 
| Development of Lung injury | Measured by a Pa02/Fi02 ratio | 31 days | 
| Time to extubation | Time from when the breathing tube was placed to the time when the breathing tube is removed | 31 days | 
| Development of Acute Kidney Injury | As measured by abnormal lab values | 31 days | 
| Initiation of renal replacement therapy | Time to start of renal replacement therapy | 31 days | 
| ICU length of stay | This will be measured by the number of days in ICU | 31 days | 
| Evaluation of Vasopressor requirements (1) | Measurement of the amount of vasopressors given | 31 days | 
| Evaluation of Vasopressor requirements (2) | Measurement of the types of vasopressors given | 31 days | 
| Change in endothelial function measured by flow mediated dilation of the brachial artery | Measurement of brachial artery dilation in response to flow by ultrasonography | 24 hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac surgery