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
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.
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
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