Clinical trial NCT03933917: Application of Large Volume Acute Normovolemic Hemodilution in Cardiac Valve Surgery
Official title: Effect of Large Volume Acute Normovolemic Hemodilution on Perioperative Blood Transfusion and Outcomes in Cardiac Valve Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Valve Surgery
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2019-05-01
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Enrollment rate of subjects
timeFrame: Through study completion，about 8 months
measure: Completion rate of acute normovolemic hemodilution
timeFrame: Through study completion，about 8 months
measure: Additional blood transfusion beyond transfusion protocol
timeFrame: Through study completion，about 8 months
Secondary outcomes:
measure: Rate of perioperative blood transfusion
timeFrame: Through study completion，about 8 months
measure: Rate of postoperative cardiac complications
timeFrame: Through study completion，about 8 months
measure: Rate of postoperative pulmonary complications
timeFrame: Through study completion，about 8 months
measure: Rate of postoperative neurological complication
timeFrame: Through study completion，about 8 months
measure: Rate of postoperative renal complication
timeFrame: Through study completion，about 8 months
measure: Other severe complication
timeFrame: Through study completion，about 8 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The second affiliated hospital of Zhejiang University
state: Zhejiang
Study officials:
affiliation: Zhejiang University
name: Min Yan, Doctor
role: STUDY_CHAIR
References: