Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Bleeding Postoperative
  • Cardiac Disease
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 90 years
Gender
Both males and females

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 e...

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. Red blood cell transfusion is performed to correct insufficient oxygen carrying capacity or oxygen delivery, but no robust measure of tissue oxygen delivery is currently available. Specific aim 2 will address this gap in knowledge by performing absolute quantification of citric acid cycle intermediates using mass spectrometry that are markers of mitochondrial respiration. Of particular interest, increased plasma levels of succinate have been shown to be associated with trauma associated mortality and the accumulation of succinate is likely due to reversal of flow of the succinate dehydrogenase complex in the absence of oxygen (unpublished data). Measurement of these markers before and after transfusion will determine the resuscitative capacity of allogenic packed red blood cells compared to fresh autologous whole blood.

Tracking Information

NCT #
NCT03204357
Collaborators
Not Provided
Investigators
Principal Investigator: Nathan Weitzel, M.D. University of Colorado - School of Medicine Principal Investigator: Nathan Clendenen, M.D. University of Colorado - School of Medicine