Clinical trial NCT03913481: Acute Normovolemic Hemodilution in High Risk Cardiac Surgery Patients.
Official title: Acute Normovolemic Hemodilution in High-risk Cardiac Surgery Patients. A Multicentre Randomized Trial.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
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
Lead sponsor: Università Vita-Salute San Raffaele
Sponsor class: OTHER
First posted: 2019-04-12
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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%)

Primary outcomes:
measure: RBCs transfusion
timeFrame: hospital discharge, an average of 10 days
Secondary outcomes:
measure: Mortality
timeFrame: 30 days
measure: Bleeding complications
timeFrame: hospital discharge, an average of 10 days
measure: Ischemic complications
timeFrame: hospital discharge,an average of 10 days
measure: AKI
timeFrame: hospital discharge, an average of 10 days
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: OUHSC - University of Oklahoma
state: Oklahoma
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Awali
country: Bahrain
facility: Mohammed Bin Khalifa Specialist Cardiac Center
city: São Paulo
country: Brazil
facility: Dante Pazzanese Institute od Cardiology
city: São Paulo
country: Brazil
facility: Instituto do Coração - Hospital das Clínicas, Faculdade de Medicina - Universidade de São Paulo
city: Xi'an
country: China
facility: Xijing Hospital
city: Cotignola
country: Italy
facility: Maria Cecilia Hospital
state: Ravenna
city: Catania
country: Italy
facility: Azienda Ospedaliero Universitaria Policlinico "G.Rodolico - San Marco"
city: Lecce
country: Italy
facility: Città di Lecce Hospital - GVM Care & Research
city: Milano
country: Italy
facility: Ospedale San Raffaele di Milano, Italy
city: Milan
country: Italy
facility: IRCCS Policlinico San Donato
city: Milan
country: Italy
facility: IRCCS Cardiologico Monzino
city: Padua
country: Italy
facility: Azienda Ospedaliera Padova
city: Pisa
country: Italy
facility: AOU Pisana
city: Potenza
country: Italy
facility: Ospedale San Carlo
city: Rome
country: Italy
facility: Policlinico Tor Vergata
city: Rome
country: Italy
facility: Azienda Ospedaliero-Universitaria Sant'Andrea
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
city: Salerno
country: Italy
facility: San Giovanni di Dio e Ruggi d'Aragona
city: Torino
country: Italy
facility: Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
city: Torino
country: Italy
facility: Azienda Ospedaliera Ordine Mauriziano di Torino
city: Udine
country: Italy
facility: Azienda Sanitaria Universitaria Integrata di Udine
city: Astrakhan
country: Russian Federation
facility: Astrakhan Centre For Cardiac Surgery
state: Russia
city: Moscow
country: Russian Federation
facility: Moscow Clinical Scientific Center named after Loginov
state: Russia
city: Moscow
country: Russian Federation
facility: Vishnevsky National Medical Research Center of Surgery
state: Russia
city: Saint Petersburg
country: Russian Federation
facility: Saint-Petersburg State University Hospital
state: Russia
city: Novosibirsk
country: Russian Federation
facility: E. Meshalkin National Medical Research Center
city: Mecca
country: Saudi Arabia
facility: King Abdullah Medical City
city: Belgrade
country: Serbia
facility: Institute of Cardiovascular Diseases "Dedinje"
city: Singapore
country: Singapore
facility: National University Hospital
city: Chiang Mai
country: Thailand
facility: Chiang Mai University Hospital
city: Istanbul
country: Turkey
facility: Kosuyolu High Specialization Education and Research Hospital
Study officials:
affiliation: Vita-Salute University of Milano
name: Alberto Zangrillo, Prof
role: STUDY_CHAIR
References:
citation: Monaco F, Guarracino F, Vendramin I, Lei C, Zhang H, Lomivorotov V, Osinsky R, Efremov S, Gurcu 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, Kirali K, Likhvantsev V, Longhini F, Yavorovskiy A, Bellomo R, Landoni G, Zangrillo A. Acute normovolemic hemodilution in cardiac surgery: Rationale and design of a multicenter randomized trial. Contemp Clin Trials. 2024 Aug;143:107605. doi: 10.1016/j.cct.2024.107605. Epub 2024 Jun 10.
citation: Barile L, Fominskiy E, Di Tomasso N, Alpizar Castro LE, Landoni G, De Luca M, Bignami E, Sala A, Zangrillo A, Monaco F. Acute Normovolemic Hemodilution Reduces Allogeneic Red Blood Cell Transfusion in Cardiac Surgery: A Systematic Review and Meta-analysis of Randomized Trials. Anesth Analg. 2017 Mar;124(3):743-752. doi: 10.1213/ANE.0000000000001609.