Acute Normovolemic Hemodilution in High Risk Cardiac Surgery Patients.

Not Applicable

Active, not recruiting

• Conditions: C.Surgical Procedure; Cardiac
• Interventions: Procedure: Acute normovolemic hemodilution; Procedure: Standard care

• Registration Number: NCT03913481
• Lead Sponsor: Università Vita-Salute San Raffaele

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-09
• Study First Submitted QC: 2019-04-10
• Study First Posted: 2019-04-12
• Study Start: 2019-04-15
• Status Verified: 2025-01
• Primary Completion: 2025-01-19
• Last Update Submitted: 2025-02-14
• Last Update Posted: 2025-02-19
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2000

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%)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ANH	Acute normovolemic hemodilution	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.
Standard care	Standard care	No ANH

Primary Outcome Measures

Name	Time	Method
RBCs transfusion	hospital discharge, an average of 10 days	The number of patients receiving RBCs transfusion after elective cardiac surgery.

Secondary Outcome Measures

Name	Time	Method
AKI	hospital discharge, an average of 10 days	Developing of acute kidney injury
Mortality	30 days	30-day mortality
Ischemic complications	hospital discharge,an average of 10 days	* Myocardial infarction; * Stroke; * Thromboembolic events
Bleeding complications	hospital discharge, an average of 10 days	* 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

Trial Locations

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

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

Ospedale San Raffaele di Milano, Italy; 🇮🇹 Milano, Italy

IRCCS Policlinico San Donato; 🇮🇹 Milan, Italy

IRCCS Cardiologico Monzino; 🇮🇹 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, Russian Federation

Moscow Clinical Scientific Center named after Loginov; 🇷🇺 Moscow, Russia, Russian Federation

Vishnevsky National Medical Research Center of Surgery; 🇷🇺 Moscow, Russia, Russian Federation

Saint-Petersburg State University Hospital; 🇷🇺 Saint Petersburg, Russia, Russian Federation

E. Meshalkin National Medical Research Center; 🇷🇺 Novosibirsk, Russian Federation

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