Acute Normovolemic Hemodilution for Cardiac Surgery
(ANH Trial)

Recruiting in Palo Alto (17 mi)

+34 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Università Vita-Salute San Raffaele

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Alberto Zangrillo, Prof

Principal Investigator

Vita-Salute University of Milano

Eligibility Criteria

This trial is for cardiac surgery patients who need a procedure involving cardiopulmonary bypass (CPB). They must be scheduled for elective surgery and have given informed consent to participate. Details on who can't join are not provided.

Inclusion Criteria

Signed informed consent

I am planning to have surgery that is not an emergency.

I have had heart surgery with a heart-lung machine.

Treatment Details

Interventions

Acute normovolemic hemodilution (Procedure)

Trial OverviewThe study is testing acute normovolemic hemodilution (ANH) against standard care in cardiac surgeries. It aims to see if ANH reduces the need for red blood cell transfusions during hospital stays, with 2000 patients randomized to ensure reliable results.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Standard careExperimental Treatment1 Intervention

No ANH

Group II: ANHExperimental Treatment1 Intervention

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.