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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ANH | Experimental | 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. |
|
| Standard care | Other | No ANH |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acute normovolemic hemodilution | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| RBCs transfusion | The number of patients receiving RBCs transfusion after elective cardiac surgery. | hospital discharge, an average of 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | 30-day mortality | 30 days |
| Bleeding complications |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alberto Zangrillo, Prof | Vita-Salute University of Milano | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OUHSC - University of Oklahoma | Oklahoma City | Oklahoma | 73104 | United States | ||
| University of Virginia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38866095 | Background | 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. | |
| 27669554 |
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|
| Standard care | Procedure | Best available treatment without ANH |
|
| hospital discharge, an average of 10 days |
| Ischemic complications |
| hospital discharge,an average of 10 days |
| AKI | Developing of acute kidney injury | hospital discharge, an average of 10 days |
| Charlottesville |
| Virginia |
| 22903 |
| United States |
| Mohammed Bin Khalifa Specialist Cardiac Center | Awali | Bahrain | Bahrain |
| Dante Pazzanese Institute od Cardiology | São Paulo | 04012-909 | Brazil |
| Instituto do Coração - Hospital das Clínicas, Faculdade de Medicina - Universidade de São Paulo | São Paulo | 05403-000 | Brazil |
| Xijing Hospital | Xi'an | 710032 | China |
| Maria Cecilia Hospital | Cotignola | Ravenna | Italy |
| Azienda Ospedaliero Universitaria Policlinico "G.Rodolico - San Marco" | Catania | 95123 | Italy |
| Città di Lecce Hospital - GVM Care & Research | Lecce | 73100 | Italy |
| IRCCS Policlinico San Donato | Milan | 20097 | Italy |
| IRCCS Cardiologico Monzino | Milan | 20138 | Italy |
| Ospedale San Raffaele di Milano, Italy | Milan | 20132 | Italy |
| Azienda Ospedaliera Padova | Padua | 35129 | Italy |
| AOU Pisana | Pisa | 56126 | Italy |
| Ospedale San Carlo | Potenza | 85100 | Italy |
| Policlinico Tor Vergata | Rome | 00133 | Italy |
| Azienda Ospedaliero-Universitaria Sant'Andrea | Rome | 00189 | Italy |
| Istituto Clinico Humanitas | Rozzano | 20089 | Italy |
| San Giovanni di Dio e Ruggi d'Aragona | Salerno | 84131 | Italy |
| Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino | Torino | 10126 | Italy |
| Azienda Ospedaliera Ordine Mauriziano di Torino | Torino | 10128 | Italy |
| Azienda Sanitaria Universitaria Integrata di Udine | Udine | 33100 | Italy |
| Astrakhan Centre For Cardiac Surgery | Astrakhan | 414011 | Russia |
| Moscow Clinical Scientific Center named after Loginov | Moscow | 111123 | Russia |
| Vishnevsky National Medical Research Center of Surgery | Moscow | 117997 | Russia |
| E. Meshalkin National Medical Research Center | Novosibirsk | Russia |
| Saint-Petersburg State University Hospital | Saint Petersburg | 190103 | Russia |
| King Abdullah Medical City | Mecca | 24246 | Saudi Arabia |
| Institute of Cardiovascular Diseases "Dedinje" | Belgrade | 11040 | Serbia |
| National University Hospital | Singapore | 119074 | Singapore |
| Chiang Mai University Hospital | Chiang Mai | 50200 | Thailand |
| Kosuyolu High Specialization Education and Research Hospital | Istanbul | Turkey | 34903 | Turkey (Türkiye) |
| Background |
| 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. |
| 40503713 | Derived | 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. |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D002056 | Burns |
| D018805 | Sepsis |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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