Clinical Research Directory
Browse clinical research sites, groups, and studies.
Acute Normovolemic Hemodilution in High Risk Cardiac Surgery Patients.
Sponsor: Università Vita-Salute San Raffaele
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.
Official title: Acute Normovolemic Hemodilution in High-risk Cardiac Surgery Patients. A Multicentre Randomized Trial.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
2000
Start Date
2019-04-15
Completion Date
2025-12
Last Updated
2025-08-07
Healthy Volunteers
No
Conditions
Interventions
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
Locations (32)
OUHSC - University of Oklahoma
Oklahoma City, Oklahoma, United States
University of Virginia
Charlottesville, Virginia, United States
Mohammed Bin Khalifa Specialist Cardiac Center
Awali, Bahrain, 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, Italy
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 (Türkiye)