Acute Normovolemic Hemodilution in High Risk Cardiac Surgery Patients. (ANH)

Università Vita-Salute San Raffaele

Status: Active, not recruiting

Conditions: C.Surgical Procedure; Cardiac

Treatments: Procedure: Standard care; Procedure: Acute normovolemic hemodilution

Study type: Interventional

Funder types: Other

Identifiers

NCT03913481

ANH/35/OSR

Details and patient eligibility

About

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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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%)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,000 participants in 2 patient groups

ANH

Experimental group

Description:

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.

Treatment:

Procedure: Acute normovolemic hemodilution

Standard care

Other group

Description:

No ANH

Treatment:

Procedure: Standard care