Acute Normovolemic Hemodilution in High Risk Cardiac Surgery Patients. (ANH)
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|ClinicalTrials.gov Identifier: NCT03913481|
Recruitment Status : Recruiting
First Posted : April 12, 2019
Last Update Posted : December 24, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|C.Surgical Procedure; Cardiac||Procedure: Acute normovolemic hemodilution Procedure: Standard care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2000 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Acute Normovolemic Hemodilution in High-risk Cardiac Surgery Patients. A Multicentre Randomized Trial.|
|Actual Study Start Date :||April 15, 2019|
|Estimated Primary Completion Date :||July 2023|
|Estimated Study Completion Date :||September 2023|
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.
Procedure: 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.
Procedure: Standard care
Best available treatment without ANH
- RBCs transfusion [ Time Frame: hospital discharge, an average of 10 days ]The number of patients receiving RBCs transfusion after elective cardiac surgery.
- Mortality [ Time Frame: 30 days ]30-day mortality
- Bleeding complications [ Time Frame: 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 [ Time Frame: hospital discharge,an average of 10 days ]
- Myocardial infarction
- Thromboembolic events
- AKI [ Time Frame: hospital discharge, an average of 10 days ]Developing of acute kidney injury
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03913481
|Contact: Giovanni Landoni, Prof||+39022643 ext firstname.lastname@example.org|
|Ospedale San Raffaele di Milano, Italy||Recruiting|
|Milano, Milano, Italy, Italy, 20132|
|Contact: Giovanni Landoni, Prof|
|Sub-Investigator: Fabrizio Monaco, MD|
|Study Chair:||Alberto Zangrillo, Prof||Vita-Salute University of Milano|