An interventional study of Acute normovolemic hemodilution and Standard care in C.Surgical Procedure; Cardiac, sponsored by Università Vita-Salute San Raffaele. Active, not recruiting at 32 sites in 11 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-08.
Sponsored by Università Vita-Salute San Raffaele · Not applicable, Interventional, and Prevention
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.
2,217 studies on the registry are indexed under Wounds and Injuries; 441 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 70 across 1,424 interventional studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →Università Vita-Salute San Raffaele is the lead sponsor of 85 studies on the registry; 33 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
No ANH
Procedure: Standard care
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.
Best available treatment without ANH
RBCs transfusion
The number of patients receiving RBCs transfusion after elective cardiac surgery.
Time frame: hospital discharge, an average of 10 days
Mortality
30-day mortality
Time frame: 30 days
Bleeding complications
* 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
Time frame: hospital discharge, an average of 10 days
Ischemic complications
* Myocardial infarction * Stroke * Thromboembolic events
Time frame: hospital discharge,an average of 10 days
AKI
Developing of acute kidney injury
Time frame: hospital discharge, an average of 10 days
This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Università Vita-Salute San Raffaele