Acute Normovolemic Hemodilution (ANH) in Patients Undergoing Cardiac Surgery

NCT04127825 | Completed

• 1 other identifier: ANES-2017-25808
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Surgery--Complications; Blood Transfusion Complication

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

Acute Normovolemic Hemodilution (ANH)

EXPERIMENTAL

Acute normovolemic hemodilution (ANH) is a blood conservation technique that entails the removal of blood from a patient shortly after induction of anesthesia, with maintenance of normovolemia using crystalloid and/or colloid replacement.

Procedure: Acute Normovolemic Hemodilution (ANH)

Standard of Care

NO INTERVENTION

Standard of care for blood volume maintenance during surgery

Interventions

Acute Normovolemic Hemodilution (ANH) PROCEDURE

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.

Acute Normovolemic Hemodilution (ANH)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• Hemoglobin concentration \< 12 g/dl
• Patients undergoing cardiac surgery without the use of cardiopulmonary bypass

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota Medical Center

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Transfusion Reaction

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2019
• First Posted: October 16, 2019
• Study Start: November 1, 2017
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: March 17, 2022

Record last verified: 2022-03

Locations

US (1)