Fresh Autologous Whole Blood Transfusion After Cardiopulmonary Bypass
- Conditions
- Bleeding PostoperativeCardiac Disease
- Interventions
- Other: Standard of Care Expectant management of bleedingOther: Fresh Autologous whole Blood
- Registration Number
- NCT03204357
- Lead Sponsor
- University of Colorado, Denver
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 70
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard of Care Expectant Management of bleeding Standard of Care Expectant management of bleeding the control group that will receive the standard of care expectant management of bleeding and transfusion of allogenic banked blood products Fresh Autologous whole blood transfusion Fresh Autologous whole Blood 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.
- Primary Outcome Measures
Name Time Method Estimated Blood Loss Within 24 hours after surgery Blood loss is estimated as a percent of total estimated blood volume in the first 24 hours after cardiac surgery.
- Secondary Outcome Measures
Name Time Method Development of Myocardial Infarction 31 days As measured by physiological parameters
Number of allogenic transfusions given 31 days Allogenic blood product transfusion requirements
Development of Lung injury 31 days Measured by a Pa02/Fi02 ratio
ICU length of stay 31 days This will be measured by the number of days in ICU
Development of Post-operative delirium 31 days Measured by Confusion Assessment Method - Intensive Care Unit
Development of Acute Kidney Injury 31 days As measured by abnormal lab values
Incident of peri-operative stroke 31 days The incident of peri-operative stroke will be measured by the National institute of health stroke scale
Detection of New Onset Atrial fibrillation 31 days As measured by an electrocardiogram
Evaluation of Vasopressor requirements (2) 31 days Measurement of the types of vasopressors given
Severity of peri-operative stroke 31 days The severity of peri-operative stroke will be measured by the National institute of health stroke scale
Initiation of renal replacement therapy 31 days Time to start of renal replacement therapy
Development of Heart failure 31 days As measured by physiological parameters
Time to extubation 31 days Time from when the breathing tube was placed to the time when the breathing tube is removed
Evaluation of Vasopressor requirements (1) 31 days Measurement of the amount of vasopressors given
Change in endothelial function measured by flow mediated dilation of the brachial artery 24 hours after surgery Measurement of brachial artery dilation in response to flow by ultrasonography
Trial Locations
- Locations (1)
University of Colorado Hospital
🇺🇸Aurora, Colorado, United States