Acute Normovolemic Hemodilution in High Risk Cardiac Surgery Patients.
NCT ID: NCT03913481
Last Updated: 2025-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
2000 participants
INTERVENTIONAL
2019-04-15
2025-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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ANH
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.
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
No ANH
Standard care
Best available treatment without ANH
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Any cardiac surgical intervention on CPB
* Elective surgery
Exclusion Criteria
* 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%)
18 Years
ALL
No
Sponsors
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Università Vita-Salute San Raffaele
OTHER
Responsible Party
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Giovanni Landoni
MD, Associate Professor
Principal Investigators
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Alberto Zangrillo, Prof
Role: STUDY_CHAIR
Vita-Salute University of Milano
Locations
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OUHSC - University of Oklahoma
Oklahoma City, Oklahoma, United States
University of Virginia
Charlottesville, Virginia, United States
Mohammed Bin Khalifa Specialist Cardiac Center
Awali, Bahrain, Bahrain
Dante Pazzanese Institute od Cardiology
São Paulo, , Brazil
Instituto do Coração - Hospital das Clínicas, Faculdade de Medicina - Universidade de São Paulo
São Paulo, , Brazil
Xijing Hospital
Xi'an, , China
Maria Cecilia Hospital
Cotignola, Ravenna, Italy
Azienda Ospedaliero Universitaria Policlinico "G.Rodolico - San Marco"
Catania, , Italy
Città di Lecce Hospital - GVM Care & Research
Lecce, , Italy
IRCCS Policlinico San Donato
Milan, , Italy
IRCCS Cardiologico Monzino
Milan, , Italy
Ospedale San Raffaele di Milano, Italy
Milan, , Italy
Azienda Ospedaliera Padova
Padua, , Italy
AOU Pisana
Pisa, , Italy
Ospedale San Carlo
Potenza, , Italy
Policlinico Tor Vergata
Rome, , Italy
Azienda Ospedaliero-Universitaria Sant'Andrea
Rome, , Italy
Istituto Clinico Humanitas
Rozzano, , Italy
San Giovanni di Dio e Ruggi d'Aragona
Salerno, , Italy
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
Torino, , Italy
Azienda Ospedaliera Ordine Mauriziano di Torino
Torino, , Italy
Azienda Sanitaria Universitaria Integrata di Udine
Udine, , Italy
Astrakhan Centre For Cardiac Surgery
Astrakhan, , Russia
Moscow Clinical Scientific Center named after Loginov
Moscow, , Russia
Vishnevsky National Medical Research Center of Surgery
Moscow, , Russia
E. Meshalkin National Medical Research Center
Novosibirsk, , Russia
Saint-Petersburg State University Hospital
Saint Petersburg, , Russia
King Abdullah Medical City
Mecca, , Saudi Arabia
Institute of Cardiovascular Diseases "Dedinje"
Belgrade, , Serbia
National University Hospital
Singapore, , Singapore
Chiang Mai University Hospital
Chiang Mai, , Thailand
Kosuyolu High Specialization Education and Research Hospital
Istanbul, , Turkey (Türkiye)
Countries
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References
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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.
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.
Monaco F, Lei C, Bonizzoni MA, Efremov S, Morselli F, Guarracino F, Giardina G, Arangino C, Pontillo D, Vitiello M, Belletti A, Ajello V, Licheri M, Nigro Neto C, Barucco G, Bukamal NA, Faustini C, Mantovani LF, Oriani A, Santonocito C, Mucchetti M, Federici F, Gerli C, Porta S, Scandroglio AM, Zhang H, Pieri M, Osinsky R, Lazzari S, Leonova E, Calabro MG, Amitrano D, Turi S, Prati P, Fresilli S, D'Amico F, D'Andria Ursoleo J, Labanca R, Marmiere M, Pruna A, Scquizzato T, Kirali K, Monti G, Carmona MJC, Tanaka K, Likhvantsev V, Ti LK, Bove T, Paternoster G, Singh K, Gurcu ME, Lomivorotov V, Landoni G, Bellomo R, Zangrillo A; ANH Study Group. A Randomized Trial of Acute Normovolemic Hemodilution in Cardiac Surgery. N Engl J Med. 2025 Jul 31;393(5):450-460. doi: 10.1056/NEJMoa2504948. Epub 2025 Jun 12.
Other Identifiers
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ANH/35/OSR
Identifier Type: -
Identifier Source: org_study_id
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