Acute Normovolemic Hemodilution in High Risk Cardiac Surgery Patients. (ANH)

May 5, 2026 updated by: Giovanni Landoni, Università Vita-Salute San Raffaele

Acute Normovolemic Hemodilution in High-risk Cardiac Surgery Patients. A Multicentre Randomized Trial.

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

2000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bahrain
    • Bahrain
      • Awali, Bahrain, Bahrain
        • Mohammed Bin Khalifa Specialist Cardiac Center
  • Brazil
      • São Paulo, Brazil, 04012-909
        • Dante Pazzanese Institute od Cardiology
      • São Paulo, Brazil, 05403-000
        • Instituto do Coração - Hospital das Clínicas, Faculdade de Medicina - Universidade de São Paulo
  • China
      • Xi'an, China, 710032
        • Xijing Hospital
  • Italy
      • Catania, Italy, 95123
        • Azienda Ospedaliero Universitaria Policlinico "G.Rodolico - San Marco"
      • Lecce, Italy, 73100
        • Città di Lecce Hospital - GVM Care & Research
      • Milan, Italy, 20097
        • IRCCS Policlinico San Donato
      • Milan, Italy, 20138
        • IRCCS Cardiologico Monzino
      • Milan, Italy, 20132
        • Ospedale San Raffaele di Milano, Italy
      • Padua, Italy, 35129
        • Azienda Ospedaliera Padova
      • Pisa, Italy, 56126
        • AOU Pisana
      • Potenza, Italy, 85100
        • Ospedale San Carlo
      • Rome, Italy, 00133
        • Policlinico Tor Vergata
      • Rome, Italy, 00189
        • Azienda Ospedaliero-Universitaria Sant'Andrea
      • Rozzano, Italy, 20089
        • Istituto Clinico Humanitas
      • Salerno, Italy, 84131
        • San Giovanni di Dio e Ruggi d'Aragona
      • Torino, Italy, 10128
        • Azienda Ospedaliera Ordine Mauriziano Di Torino
      • Torino, Italy, 10126
        • Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
      • Udine, Italy, 33100
        • Azienda Sanitaria Universitaria integrata di Udine
    • Ravenna
      • Cotignola, Ravenna, Italy
        • Maria Cecilia Hospital
  • Russia
      • Astrakhan, Russia, 414011
        • Astrakhan Centre For Cardiac Surgery
      • Moscow, Russia, 111123
        • Moscow Clinical Scientific Center named after Loginov
      • Moscow, Russia, 117997
        • Vishnevsky National Medical Research Center of Surgery
      • Novosibirsk, Russia
        • E. Meshalkin National Medical Research Center
      • Saint Petersburg, Russia, 190103
        • Saint-Petersburg State University Hospital
  • Saudi Arabia
      • Mecca, Saudi Arabia, 24246
        • King Abdullah Medical City
  • Serbia
      • Belgrade, Serbia, 11040
        • Institute of Cardiovascular Diseases "Dedinje"
  • Singapore
      • Singapore, Singapore, 119074
        • National University Hospital
  • Thailand
      • Chiang Mai, Thailand, 50200
        • Chiang Mai University Hospital
  • Turkey (Türkiye)
    • Turkey
      • Istanbul, Turkey, Turkey (Türkiye), 34903
        • Kosuyolu High Specialization Education and Research Hospital
  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • OUHSC - University of Oklahoma
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Signed informed consent
  • Any cardiac surgical intervention on CPB
  • Elective surgery

Exclusion Criteria:

  • Medical decision (e.g.: planned pre-CPB ANH considered undeniable for ethical reasons or not applicable for safety issues)
  • Unstable Coronary Artery Disease: Recent (< 6 weeks) myocardial infarction, unstable angina, severe (> 70%) left main coronary artery stenosis
  • Critical preoperative state (ventricular tachycardia or ventricular fibrillation or aborted sudden death, preoperative cardiac massage, preoperative ventilation before anesthetic room, hemodynamic instability, preoperative inotropes or IABP, preoperative severe acute renal failure (anuria or oliguria <10ml/hr.)
  • Emergency surgery
  • Pregnancy
  • Unfeasibility to withdraw ≥ 650 ml without inducing hemodynamic instability
  • Unfeasibility to withdraw ≥ 650 ml without inducing pre-CPB anemia (Htc <30%)
  • Unfeasibility to withdraw ≥ 650 ml without inducing low Htc during CPB (Htc <24%)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ANH
Best available treatments plus ANH, performed withdrawing a volume of blood before the CPB. The volume will be personalized for every patient, but it'll be at least 650ml.
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.
Other: Standard care
No ANH
Procedure: Standard care
Best available treatment without ANH

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RBCs transfusion
Time Frame: hospital discharge, an average of 10 days
The number of patients receiving RBCs transfusion after elective cardiac surgery.
hospital discharge, an average of 10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 30 days
30-day mortality
30 days
Bleeding complications
Time Frame: hospital discharge, an average of 10 days
  • Amount of blood components (RBC, fresh frozen plasma-FFP, platelet -PLT) transfused (units/ml)
  • Estimated total blood volume lost (ml) at 12 hours after surgery
  • Surgical revision for bleeding
hospital discharge, an average of 10 days
Ischemic complications
Time Frame: hospital discharge,an average of 10 days
  • Myocardial infarction
  • Stroke
  • Thromboembolic events
hospital discharge,an average of 10 days
AKI
Time Frame: hospital discharge, an average of 10 days
Developing of acute kidney injury
hospital discharge, an average of 10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università Vita-Salute San Raffaele

Investigators

  • Study Chair: Alberto Zangrillo, Prof, Vita-Salute University of Milano

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2019

Primary Completion (Actual)

January 19, 2025

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

April 9, 2019

First Submitted That Met QC Criteria

April 10, 2019

First Posted (Actual)

April 12, 2019

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 5, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANH/35/OSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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