Application of Large Volume Acute Normovolemic Hemodilution in Cardiac Valve Surgery

Study Overview
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Brief Summary
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The application of acute Normovolemic Hemodilution in cardiac surgery can effectively reduce perioperative blood transfusion, reduce postoperative complications and mortality, and is a low-cost, operable and effective blood protection measure.For the application of Acute Normovolemic Hemodilution in heart surgery, we still face an urgent problem: to what extent can Acute Normovolemic Hemodilution achieve better blood saving effect, that is, whether a large number of Acute Normovolemic Hemodilution can reduce perioperative blood transfusion to a greater extent.

Official Title
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Effect of Large Volume Acute Normovolemic Hemodilution on Perioperative Blood Transfusion and Outcomes in Cardiac Valve Surgery

Conditions
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Cardiac Valve Surgery

Intervention / Treatment
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* Procedure: Acute Normovolemic Hemodilution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Audlt patients ( ≥ 18 years old); elective valve surgery under cardiopulmonary bypass; Preoperative hemoglobin (Hb) ≥ 12g/dl; (4) Transfusion Risk Understanding Scoring Tool (TRUST) ≥ 2 (possibility of blood transfusion ≥40%). Exclusion Criteria: （1）Low body weight (male: <50 kg;Female: < 45kg);（2）preoperative shock；（3）myocardial infarction within 3 months before surgery；（4）ischemic heart disease;Left main coronary artery stenosis >70%;Severe aortic stenosis (area < 0.7cm2);Severe changes in left ventricular function (ejection fraction <30%, requiring vasoactive agents to assist circulation);（5）uncontrolled hypertension;（6） severe carotid artery stenosis (>70% or with symptoms);（7） kidney failure (blood creatinine level >442 mmol/L) or dialysis treatment;（8） serum albumin level (ALB) is less than 25 g/L.（9） international standardized ratio (INR) >1.5 or platelet count <100 103/mm3;（10）Inherited/acquired coagulation function defect;（11）preoperative preparation platelet;（12） contagious or infectious diseases;（13） patient or family members refused to participate in research;（14）refused to infusion of autologous blood or allogeneic blood products

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Large Volume Acute Normovolemic Hemodilution<br>All the participants will undergo Large Volume Acute Normovolemic Hemodilution. | Procedure: Acute Normovolemic Hemodilution<br>* Following induction of anesthesia, the volume of blood to be removed during Acute Normovolemic Hemodilution was calculated using an established formula:V=Weight（Kg）×12-15（mL/Kg）;Blood to be removed was capped at： Vmax=EVB×(Hi-Hf)/Hav（EBV= estimated blood volume （male:70mL/Kg，female:65mL/Kg）；Hi= initial hemoglobin ；Hf=target Hb（ 10g/dL ）；Hav= the average of the initial and minimal allowable hemoglobin）.Ensure the volume of removed blood does not exceed the upper limit and Hb ≥10g/dL after blood removed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Enrollment rate of subjects | The percentage of patients who completed the study | Through study completion，about 8 months | 
| Completion rate of acute normovolemic hemodilution | The percentage of patients who complete large volume of acute normovolemic hemodilution | Through study completion，about 8 months | 
| Additional blood transfusion beyond transfusion protocol | Nonstandard blood transfusion | Through study completion，about 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of perioperative blood transfusion | The percentage of red blood, fresh frozen plasma and platelet transfusion | Through study completion，about 8 months | 
| Rate of postoperative cardiac complications | Including myocardial infarction, heart failure, low cardiac output, pericardial tamponade, severe arrhythmia according to physical and laboratory examination | Through study completion，about 8 months | 
| Rate of postoperative pulmonary complications | Including moderate and massive pleural effusion, respiratory failure, re-intubation according to physical and laboratory examination | Through study completion，about 8 months | 
| Rate of postoperative neurological complication | Including cerebral hemorrhage, cerebral infarction according to physical and laboratory examination | Through study completion，about 8 months | 
| Rate of postoperative renal complication | Need renal replacement therapy | Through study completion，about 8 months | 
| Other severe complication | Including re-operation, re-admission of intensive care unit, multiple organ dysfunction, all cause death according to physical and laboratory examination and medical record | Through study completion，about 8 months |