Cardiac Valve Surgery
Conditions
Brief summary
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.
Interventions
PROCEDUREAcute Normovolemic Hemodilution
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.
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Audlt patients ( ≥ 18 years old); 2. elective valve surgery under cardiopulmonary bypass; 3. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enrollment rate of subjects | Through study completion，about 8 months | The percentage of patients who completed the study |
| Completion rate of acute normovolemic hemodilution | Through study completion，about 8 months | The percentage of patients who complete large volume of acute normovolemic hemodilution |
| Additional blood transfusion beyond transfusion protocol | Through study completion，about 8 months | Nonstandard blood transfusion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of postoperative neurological complication | Through study completion，about 8 months | Including cerebral hemorrhage, cerebral infarction according to physical and laboratory examination |
| Rate of perioperative blood transfusion | Through study completion，about 8 months | The percentage of red blood, fresh frozen plasma and platelet transfusion |
| Other severe complication | Through study completion，about 8 months | Including re-operation, re-admission of intensive care unit, multiple organ dysfunction, all cause death according to physical and laboratory examination and medical record |
| Rate of postoperative renal complication | Through study completion，about 8 months | Need renal replacement therapy |
| Rate of postoperative cardiac complications | Through study completion，about 8 months | Including myocardial infarction, heart failure, low cardiac output, pericardial tamponade, severe arrhythmia according to physical and laboratory examination |
| Rate of postoperative pulmonary complications | Through study completion，about 8 months | Including moderate and massive pleural effusion, respiratory failure, re-intubation according to physical and laboratory examination |
Countries
China
Outcome results
None listed