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NCT04127825 · ClinicalTrials.gov registry record · NA

Acute Normovolemic Hemodilution (ANH) in Patients Undergoing Cardiac Surgery

A NA study, sponsored by University of Minnesota.

Completed
Registry status
NA
Development phase
2
Enrollment target

NCT04127825: Completed NA study, sponsored by University of Minnesota.

NCT04127825 is a NA study that has completed, run by University of Minnesota. The registered enrollment target is 2 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04127825, a NA study, has completed, sponsored by University of Minnesota.

COMPLETED
Registry status
NA
Development phase
2 participants
Enrollment target

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.

Primary Outcome

The total volume (reported in ml) of blood products transfused intraoperatively. A lower volume of transfused blood products indicates greater efficacy of the intervention.

Interventions

  • PROCEDURE Acute Normovolemic Hemodilution (ANH)

Trial Details

FieldValue
Enrollment Target 2 participants
Start Date 2017-11-01
Est. Completion 2021-04-30
Phase NA
University of Minnesota

966 total trials

What the finished NCT04127825 record still lists

NCT04127825 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).

The record links to 0 conditions, and to 1 intervention - of which Acute Normovolemic Hemodilution (ANH) is the first listed.

NCT04127825 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04127825 about?

NCT04127825 is a clinical study titled "Acute Normovolemic Hemodilution (ANH) in Patients Undergoing Cardiac Surgery". 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 (w...

What is the current status of trial NCT04127825?

This trial is currently completed. It is a NA study. The enrollment target is 2 participants. The study started on 2017-11-01. Estimated completion is 2021-04-30.

What interventions are being tested in trial NCT04127825?

The interventions under investigation include: Acute Normovolemic Hemodilution (ANH) (PROCEDURE).

Who is sponsoring clinical trial NCT04127825?

This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04127825's enrollment target sits among peer trials

2 1997th of 2000 the lowest of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04127825, the US trial registry maintained by the National Library of Medicine. NCT04127825 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.