Acute Normovolemic Hemodilution (ANH) in Patients Undergoing Cardiac Surgery

NCT04127825 NA COMPLETED

The purpose of this small randomized pilot study is to evaluate adherence to strict transfusion protocols in both the control and ANH group examining compliant and noncompliant transfusion rates and reasons for violation of the protocol if present. Data on transfusion requirements for both groups (with and without ANH) will be evaluated to determine sample size and feasibility of performing a larger study on ANH in our patient population. The ultimate purpose of a larger study would be to determine if acute normovolemic hemodilution results in a reduction in red blood cell units transfused in patients undergoing cardiac surgery involving cardiopulmonary bypass (CPB) and to carefully determine provider adherence to specific transfusion triggers for the administration of each unit of harvested and banked blood transfused. Secondary endpoints that will be evaluated in a larger study include any difference in the number of other blood products transfused including fresh frozen plasma, platelets, and cryoprecipitate as well as differences in coagulation status as measured by thromboelastography (TEG), INR/PTT, platelet count, and fibrinogen level, and ICU/hospital length of stay.

Details

Lead sponsor	University of Minnesota
Phase	NA
Status	COMPLETED
Enrolment	2
Start date	Wed Nov 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Fri Apr 30 2021 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Surgery--Complications
• Blood Transfusion Complication

Interventions

• Acute Normovolemic Hemodilution (ANH)

Countries

United States