Acute Normovolemic Hemodilution in High Risk Cardiac Surgery Patients.

Study Overview
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Brief Summary
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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.

Official Title
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Acute Normovolemic Hemodilution in High-risk Cardiac Surgery Patients. A Multicentre Randomized Trial.

Conditions
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C.Surgical Procedure; Cardiac

Intervention / Treatment
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* Procedure: Acute normovolemic hemodilution
* Procedure: Standard care


Participation Criteria
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Eligibility Criteria
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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%)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ANH<br>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<br>* 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.<br>|
| Other: Standard care<br>No ANH | Procedure: Standard care<br>* Best available treatment without ANH<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac surgery, tissue, organ and systemic injury responses to surgery, trauma, burn, sepsis, hemorrhage, ischemia- reperfusion, resuscitation, including integrating pathways and signals, transfusion