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Acute Normovolemic Hemodilution (ANH) in Patients Undergoing Cardiac Surgery

NCT04127825 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2022-03-17

No results posted yet for this study

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

Interventions

PROCEDURE

Acute Normovolemic Hemodilution (ANH)

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-01
Primary Completion
2021-04-30
Completion
2021-04-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04127825 on ClinicalTrials.gov