Acute Normovolemic Hemodilution in High Risk Cardiac Surgery Patients.

C.Surgical Procedure; Cardiac Clinical Trial

— ANH  

Official title:

Acute Normovolemic Hemodilution in High-risk Cardiac Surgery Patients. A Multicentre Randomized Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03913481
• Other study ID #: ANH/35/OSR
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2019
• Est. completion date: March 2025

Study information

• Verified date: January 2024
• Source: Università Vita-Salute San Raffaele
• Contact: Giovanni Landoni, Prof
• Phone: +39022643
• Email: landoni.giovanni[@]hsr.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: March 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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%)

Related Conditions & MeSH terms

• C.Surgical Procedure; Cardiac

Intervention

Procedure:
• 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

Country	Name	City	State
Italy	Maria Cecilia Hospital	Cotignola	Ravenna
Italy	Città di Lecce Hospital	Lecce	Puglia
Italy	Ospedale San Raffaele di Milano, Italy	Milano	Milano, Italy
Italy	AOU Pisana	Pisa
Italy	AOR San Carlo	Potenza
Russian Federation	Astrakhan Centre For Cardiac Surgery	Astrakhan
Russian Federation	State Research Institute of Circulation Pathology	Novosibirsk
Russian Federation	Saint-Petersburg State University Hospital	Saint Petersburg
Saudi Arabia	King Abdullah Medical City	Mecca
Serbia	Institute of Cardiovascular Diseases "Dedinje"	Belgrade
Singapore	National University Hospital	Singapore
Thailand	Chiang Mai University Hospital	Chiang Mai

Sponsors (1)

Lead Sponsor	Collaborator
Università Vita-Salute San Raffaele

Countries where clinical trial is conducted

Italy,  Russian Federation,  Saudi Arabia,  Serbia,  Singapore,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RBCs transfusion	The number of patients receiving RBCs transfusion after elective cardiac surgery.	hospital discharge, an average of 10 days
Secondary	Mortality	30-day mortality	30 days
Secondary	Bleeding complications	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	hospital discharge, an average of 10 days
Secondary	Ischemic complications	Myocardial infarction; Stroke; Thromboembolic events	hospital discharge,an average of 10 days
Secondary	AKI	Developing of acute kidney injury	hospital discharge, an average of 10 days