🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Contributor sign in
Latest
Clinical Trials in Italy / NCT03913481
Active, not recruiting Not applicable

Acute Normovolemic Hemodilution in High Risk Cardiac Surgery Patients.

NCT03913481 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2019-04-15
Last updated
2026-05-08

Condition(s) studied

C.Surgical Procedure; Cardiac

Investigational drug(s) / intervention(s)

Acute normovolemic hemodilutionStandard care

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.

Standard care: Best available treatment without ANH

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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%)

Primary outcome measure(s)

Trial sites (32)

FacilityCityRegionStatus
OUHSC - University of Oklahoma Oklahoma City Oklahoma
University of Virginia Charlottesville Virginia
Mohammed Bin Khalifa Specialist Cardiac Center Awali Bahrain
Dante Pazzanese Institute od Cardiology São Paulo Brazil
Instituto do Coração - Hospital das Clínicas, Faculdade de Medicina - Universidade de São Paulo São Paulo Brazil
Xijing Hospital Xi'an China
Maria Cecilia Hospital Cotignola Ravenna
Azienda Ospedaliero Universitaria Policlinico "G.Rodolico - San Marco" Catania Italy
Città di Lecce Hospital - GVM Care & Research Lecce Italy
IRCCS Policlinico San Donato Milan Italy
IRCCS Cardiologico Monzino Milan Italy
Ospedale San Raffaele di Milano, Italy Milan Italy
Azienda Ospedaliera Padova Padua Italy
AOU Pisana Pisa Italy
Ospedale San Carlo Potenza Italy
Policlinico Tor Vergata Rome Italy
Azienda Ospedaliero-Universitaria Sant'Andrea Rome Italy
Istituto Clinico Humanitas Rozzano Italy
San Giovanni di Dio e Ruggi d'Aragona Salerno Italy
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino Torino Italy
Azienda Ospedaliera Ordine Mauriziano di Torino Torino Italy
Azienda Sanitaria Universitaria Integrata di Udine Udine Italy
Astrakhan Centre For Cardiac Surgery Astrakhan Russia
Moscow Clinical Scientific Center named after Loginov Moscow Russia
Vishnevsky National Medical Research Center of Surgery Moscow Russia
E. Meshalkin National Medical Research Center Novosibirsk Russia
Saint-Petersburg State University Hospital Saint Petersburg Russia
King Abdullah Medical City Mecca Saudi Arabia
Institute of Cardiovascular Diseases "Dedinje" Belgrade Serbia
National University Hospital Singapore Singapore
Chiang Mai University Hospital Chiang Mai Thailand
Kosuyolu High Specialization Education and Research Hospital Istanbul Turkey

More Università Vita-Salute San Raffaele trials in Italy

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03913481 on ClinicalTrials.gov ↗ ← All trials in Italy