Acute Normovolemic Hemodilution in High Risk Cardiac Surgery Patients.

Not Applicable

Active, not recruiting

• Conditions: C.Surgical Procedure; Cardiac

• 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
• Primary Completion: 2025-01-19
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-05
• Last Update Posted: 2025-08-07
• Study Completion: 2025-12-01

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

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
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
AKI	hospital discharge, an average of 10 days	Developing of acute kidney injury

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

Scroll for more (22 remaining)