Effect of Large Volume Acute Normovolemic Hemodilution on Perioperative Blood Transfusion and Outcomes in Cardiac Valve Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 74
- Locations
- 1
- Primary Endpoint
- Enrollment rate of subjects
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Enrollment rate of subjects
Time Frame: Through study completion，about 8 months
The percentage of patients who completed the study
Completion rate of acute normovolemic hemodilution
Time Frame: Through study completion，about 8 months
The percentage of patients who complete large volume of acute normovolemic hemodilution
Additional blood transfusion beyond transfusion protocol
Time Frame: Through study completion，about 8 months
Nonstandard blood transfusion
Secondary Outcomes
- Rate of perioperative blood transfusion(Through study completion，about 8 months)
- Rate of postoperative cardiac complications(Through study completion，about 8 months)
- Rate of postoperative pulmonary complications(Through study completion，about 8 months)
- Rate of postoperative neurological complication(Through study completion，about 8 months)
- Rate of postoperative renal complication(Through study completion，about 8 months)
- Other severe complication(Through study completion，about 8 months)