MedTrace Logo

Acute Normovolemic Hemodilution in High Risk Cardiac Surgery Patients.

NCT03913481 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2000

Last updated 2026-05-08

No results posted yet for this study

Summary

Transfusions are one of the most overused treatments in modern medicine, and saving blood is one important issue all around the world. Cardiac surgery makes up a large percentage of the overall blood components consumption in surgery.

Acute normovolemic hemo-dilution (ANH) is a well-known strategy which has been used for years without the support of high quality evidence based medicine to improve post-cardiopulmonary bypass coagulation and reduce red blood cells (RBC) transfusion. We designed a multicenter randomized controlled trial to investigate the effect of ANH in reducing the number of cardiac surgery patients receiving RBC transfusions during hospital stay. We will randomize 2000 patients to have sufficient power to demonstrate a 20% relative and 7% absolute risk reduction in the number of patients' RBC transfusion. If the results of the study will confirm our hypothesis, this will have a great impact on blood management in cardiac operating room.

Conditions

  • C.Surgical Procedure; Cardiac

Interventions

PROCEDURE

Acute normovolemic hemodilution

In the ANH arm, after induction of general anesthesia, a total blood volume of at least 650 ml of blood will be drawn from a central line. The amount of volume drawn can be replaced with Ringer lactate or a similar crystalloid fluid up to a 3:1 ratio.

PROCEDURE

Standard care

Best available treatment without ANH

Sponsors & Collaborators

  • Università Vita-Salute San Raffaele

    lead OTHER

Principal Investigators

  • Alberto Zangrillo, Prof · Vita-Salute University of Milano

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-15
Primary Completion
2025-01-19
Completion
2026-12-31

Countries

  • United States
  • Bahrain
  • Brazil
  • China
  • Italy
  • Russia
  • Saudi Arabia
  • Serbia
  • Singapore
  • Thailand
  • Turkey (Türkiye)

Study Locations

More Related Trials

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 NCT03913481 on ClinicalTrials.gov