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Can removing blood before heart surgery cut transfusions? large trial aims to find out.

NCT ID NCT03913481

Disease control Sponsor: Università Vita-Salute San Raffaele Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a technique called acute normovolemic hemodilution (ANH) in 2000 high-risk heart surgery patients. Before the heart-lung machine is used, doctors remove some blood and replace it with fluids. The goal is to see if this reduces the number of patients who need a blood transfusion during their hospital stay. The trial compares ANH to standard care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Acute normovolemic hemodilution (a procedure where some blood is removed before surgery and replaced with fluids)
What this could lead to
If it works, this simple procedure could reduce the need for blood transfusions in heart surgery patients, saving blood and lowering risks.
What could go wrong
This is a well-known technique but still lacks strong evidence. The benefit may be small or not apply to all patients, and there are risks like low blood pressure or anemia during surgery.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 2,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2019

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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%)

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Conditions

The condition(s) this trial relates to.

burn heart disorder Hemorrhage injury Sepsis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

C.surgical procedure; cardiac

Contacts and locations

Locations

  • AOU Pisana

    Pisa, 56126, Italy

  • Astrakhan Centre For Cardiac Surgery

    Astrakhan, 414011, Russia

  • Azienda Ospedaliera Ordine Mauriziano di Torino

    Torino, 10128, Italy

  • Azienda Ospedaliera Padova

    Padua, 35129, Italy

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

    Catania, 95123, Italy

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

    Torino, 10126, Italy

  • Azienda Ospedaliero-Universitaria Sant'Andrea

    Rome, 00189, Italy

  • Azienda Sanitaria Universitaria Integrata di Udine

    Udine, 33100, Italy

  • Chiang Mai University Hospital

    Chiang Mai, 50200, Thailand

  • Città di Lecce Hospital - GVM Care & Research

    Lecce, 73100, Italy

  • Dante Pazzanese Institute od Cardiology

    São Paulo, 04012-909, Brazil

  • E. Meshalkin National Medical Research Center

    Novosibirsk, Russia

  • IRCCS Cardiologico Monzino

    Milan, 20138, Italy

  • IRCCS Policlinico San Donato

    Milan, 20097, Italy

  • Institute of Cardiovascular Diseases "Dedinje"

    Belgrade, 11040, Serbia

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

    São Paulo, 05403-000, Brazil

  • Istituto Clinico Humanitas

    Rozzano, 20089, Italy

  • King Abdullah Medical City

    Mecca, 24246, Saudi Arabia

  • Kosuyolu High Specialization Education and Research Hospital

    Istanbul, Turkey, 34903, Turkey (Türkiye)

  • Maria Cecilia Hospital

    Cotignola, Ravenna, Italy

  • Mohammed Bin Khalifa Specialist Cardiac Center

    Awali, Bahrain, Bahrain

  • Moscow Clinical Scientific Center named after Loginov

    Moscow, 111123, Russia

  • National University Hospital

    Singapore, 119074, Singapore

  • OUHSC - University of Oklahoma

    Oklahoma City, Oklahoma, 73104, United States

  • Ospedale San Carlo

    Potenza, 85100, Italy

  • Ospedale San Raffaele di Milano, Italy

    Milan, 20132, Italy

  • Policlinico Tor Vergata

    Rome, 00133, Italy

  • Saint-Petersburg State University Hospital

    Saint Petersburg, 190103, Russia

  • San Giovanni di Dio e Ruggi d'Aragona

    Salerno, 84131, Italy

  • University of Virginia

    Charlottesville, Virginia, 22903, United States

  • Vishnevsky National Medical Research Center of Surgery

    Moscow, 117997, Russia

  • Xijing Hospital

    Xi'an, 710032, China