Recruitment

Recruitment Status
Enrolling by invitation
Estimated Enrollment
Same as current

Summary

Conditions
  • Blood Transfusion Complication
  • Surgery- Complications
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Cardiac surgery patients are typically at higher risk of receiving blood transfusions during surgery than patients presenting for most other surgical procedures. Acute normovolemic hemodilution (ANH) is a method of blood conservation used to reduce the amount of donor blood transfused. It involves r...

Cardiac surgery patients are typically at higher risk of receiving blood transfusions during surgery than patients presenting for most other surgical procedures. Acute normovolemic hemodilution (ANH) is a method of blood conservation used to reduce the amount of donor blood transfused. It involves removing blood from appropriate patients immediately after the induction of anesthesia, replacing the volume lost with colloids (e.g. 5% albumin), then storing and returning this blood to the patient at the completion of the surgical procedures. By reducing the patient's hematocrit during surgery, the blood that is shed during the procedure has a lower red blood cell volume and therefore fewer red blood cells are lost during major blood loss. In addition, the autologous stored blood contains coagulation factors that are spared and returned following the procedure. This process is already performed here and at other institutions as a potential means of reducing transfusions in high risk patients. However, in spite of multiple publications, the actual value of this procedure is unclear, in part because many of the published studies in cardiac surgical patients failed to establish firm protocol- specific guidelines for either returning harvested blood to the patient or for using banked blood, or because it is unclear whether these guidelines were actually followed during surgery (rather than left to the discretion of anesthesiologists and surgeons). The primary goal of this pilot study is to implement rigorous transfusion protocols for both ANH and routine transfusion practice and to examine compliant and noncompliant transfusion rates in both the ANH and control groups, evaluating reasons for violation of the transfusion protocol if applicable and to determine the feasibility of performing a larger study on ANH. Secondary goals for this pilot study include gathering data on transfusion rates in ANH versus control patients to determine the sample size for a larger, definitive study in which the primary goal would be to evaluate the effectiveness of ANH in reducing transfusion of banked blood units during cardiac surgery as compared to control patients in which ANH is not used. Secondary endpoints of a larger study would also include evaluating coagulation status in patients undergoing ANH versus control patients.

Tracking Information

NCT #
NCT04127825
Collaborators
Not Provided
Investigators
Not Provided