Surgery--Complications Clinical Trial
Official title:
Pilot Study on the Use of Acute Normovolemic Hemodilution (ANH) in Patients Undergoing Cardiac Surgery at the University of Minnesota
Verified date | March 2022 |
Source | University of Minnesota |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 2 |
Est. completion date | April 30, 2021 |
Est. primary completion date | April 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients undergoing cardiac surgery involving one of the following procedures at the University of Minnesota: A) combined coronary artery bypass graft and valve repair/replacement B) redo cardiac surgery C) left ventricular assist device placement Exclusion Criteria: - Hemoglobin concentration < 12 g/dl - Patients undergoing cardiac surgery without the use of cardiopulmonary bypass |
Country | Name | City | State |
---|---|---|---|
United States | University of Minnesota Medical Center | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
University of Minnesota |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total blood products transfused intraoperatively | The total volume (reported in ml) of blood products transfused intraoperatively. A lower volume of transfused blood products indicates greater efficacy of the intervention. | duration of surgery (approximately 12 hours) |
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