Acute Normovolemic Hemodilution in High Risk Cardiac Surgery Patients.

Conditions

C.Surgical Procedure; Cardiac

Keywords

tissue, organ and systemic injury responses to surgery, trauma, burn, sepsis, hemorrhage, ischemia- reperfusion, resuscitation, including integrating pathways and signals, cardiac surgery, transfusion

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.

Fabrizio Monaco, Chong Lei, Matteo Aldo Bonizzoni, Sergey Efremov, Federica Morselli et al. (55 authors)

New England Journal of Medicine2025-06-1218 citations

10.1056/nejmoa2504948

Acute normovolemic hemodilution in cardiac surgery: Rationale and design of a multicenter randomized trial.

Monaco F, Guarracino F, Vendramin I, Lei C, Zhang H, Lomivorotov V, Osinsky R, Efremov S, Gürcü ME, Mazzeffi M, Pasyuga V, Kotani Y, Biondi-Zoccai G, D'Ascenzo F, Romagnoli E, Nigro Neto C, Do Nascimento VTNDS, Ti LK, Lorsomradee S, Farag A, Bukamal N, Brizzi G, Lobreglio R, Belletti A, Arangino C, Paternoster G, Bonizzoni MA, Tucciariello MT, Kroeller D, Di Prima AL, Mantovani LF, Ajello V, Gerli C, Porta S, Ferrod F, Giardina G, Santonocito C, Ranucci M, Lembo R, Pisano A, Morselli F, Nakhnoukh C, Oriani A, Pieri M, Scandroglio AM, Kırali K, Likhvantsev V, Longhini F, Yavorovskiy A, Bellomo R, Landoni G, Zangrillo A.

2024-06-106 citations

10.1016/j.cct.2024.107605

Interventions

PROCEDUREAcute 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.

PROCEDUREStandard care

Best available treatment without ANH

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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%)

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Mortality	30 days	30-day mortality
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
Ischemic complications	hospital discharge,an average of 10 days	* Myocardial infarction * Stroke * Thromboembolic events
AKI	hospital discharge, an average of 10 days	Developing of acute kidney injury

Countries

Bahrain, Brazil, China, Italy, Russia, Saudi Arabia, Serbia, Singapore, Thailand, Turkey (Türkiye), United States

Contacts

STUDY_CHAIRAlberto Zangrillo, Prof

Vita-Salute University of Milano

Outcome results

None listed