Acute Normovolemic Hemodilution in High Risk Cardiac Surgery Patients.
Running, not enrolling · Not applicable
Conditions studied: C.Surgical Procedure; Cardiac
In brief
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.
Key facts
- Study ID
- NCT03913481
- Run by
- Università Vita-Salute San Raffaele
- People needed
- 2000
- Starts
- 2019-04-15
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-05-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Signed informed consent
- Any cardiac surgical intervention on CPB
- Elective surgery
You may not qualify if…
- 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%)
Where it is running
- 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
Full record on ClinicalTrials.gov
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