Acute Normovolemic Hemodilution in High Risk Cardiac Surgery Patients.

Last updated: August 5, 2025
Sponsor: Università Vita-Salute San Raffaele
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

N/A

Treatment

Acute normovolemic hemodilution

Standard care

Clinical Study ID

NCT03913481
ANH/35/OSR
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Signed informed consent

  • Any cardiac surgical intervention on CPB

  • Elective surgery

Exclusion

Exclusion Criteria:

  • Medical decision (e.g.: planned pre-CPB ANH considered undeniable for ethicalreasons or not applicable for safety issues)

  • Unstable Coronary Artery Disease: Recent (< 6 weeks) myocardial infarction, unstableangina, severe (> 70%) left main coronary artery stenosis

  • Critical preoperative state (ventricular tachycardia or ventricular fibrillation oraborted sudden death, preoperative cardiac massage, preoperative ventilation beforeanesthetic 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 Design

Total Participants: 2000
Treatment Group(s): 2
Primary Treatment: Acute normovolemic hemodilution
Phase:
Study Start date:
April 15, 2019
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Mohammed Bin Khalifa Specialist Cardiac Center

    Awali,
    Bahrain

    Site Not Available

  • Dante Pazzanese Institute od Cardiology

    São Paulo, 04012-909
    Brazil

    Site Not Available

  • Instituto do Coração - Hospital das Clínicas, Faculdade de Medicina - Universidade de São Paulo

    São Paulo, 05403-000
    Brazil

    Site Not Available

  • Xijing Hospital

    Xi'an, 710032
    China

    Site Not Available

  • Città di Lecce Hospital

    Lecce, Puglia
    Italy

    Site Not Available

  • Maria Cecilia Hospital

    Cotignola, Ravenna
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Policlinico "G.Rodolico - San Marco"

    Catania, 95123
    Italy

    Site Not Available

  • Città di Lecce Hospital - GVM Care & Research

    Lecce, 73100
    Italy

    Site Not Available

  • IRCCS Cardiologico Monzino

    Milan, 20138
    Italy

    Site Not Available

  • IRCCS Policlinico San Donato

    Milan, 20097
    Italy

    Site Not Available

  • Ospedale San Raffaele di Milano, Italy

    Milano, 20132
    Italy

    Site Not Available

  • Azienda Ospedaliera Padova

    Padua, 35129
    Italy

    Site Not Available

  • AOU Pisana

    Pisa, 56126
    Italy

    Site Not Available

  • AOR San Carlo

    Potenza,
    Italy

    Site Not Available

  • Ospedale San Carlo

    Potenza, 85100
    Italy

    Site Not Available

  • Azienda Ospedaliero-Universitaria Sant'Andrea

    Rome, 00189
    Italy

    Site Not Available

  • Policlinico Tor Vergata

    Rome, 00133
    Italy

    Site Not Available

  • Istituto Clinico Humanitas

    Rozzano, 20089
    Italy

    Site Not Available

  • San Giovanni di Dio e Ruggi d'Aragona

    Salerno, 84131
    Italy

    Site Not Available

  • Azienda Ospedaliera Ordine Mauriziano di Torino

    Torino, 10128
    Italy

    Site Not Available

  • Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino

    Torino, 10126
    Italy

    Site Not Available

  • Azienda Sanitaria Universitaria Integrata di Udine

    Udine, 33100
    Italy

    Site Not Available

  • Astrakhan Centre For Cardiac Surgery

    Astrakhan, 414011
    Russian Federation

    Site Not Available

  • Moscow Clinical Scientific Center named after Loginov

    Moscow, 111123
    Russian Federation

    Site Not Available

  • Vishnevsky National Medical Research Center of Surgery

    Moscow, 117997
    Russian Federation

    Site Not Available

  • E. Meshalkin National Medical Research Center

    Novosibirsk,
    Russian Federation

    Site Not Available

  • State Research Institute of Circulation Pathology

    Novosibirsk,
    Russian Federation

    Site Not Available

  • Saint-Petersburg State University Hospital

    Saint Petersburg, 190103
    Russian Federation

    Site Not Available

  • King Abdullah Medical City

    Mecca, 24246
    Saudi Arabia

    Site Not Available

  • Institute of Cardiovascular Diseases "Dedinje"

    Belgrade, 11040
    Serbia

    Site Not Available

  • National University Hospital

    Singapore, 119074
    Singapore

    Site Not Available

  • Chiang Mai University Hospital

    Chiang Mai, 50200
    Thailand

    Site Not Available

  • Kosuyolu High Specialization Education and Research Hospital

    Istanbul, 34903
    Turkey

    Site Not Available

  • OUHSC - University of Oklahoma

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • University of Virginia

    Charlottesville, Virginia 22903
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.