Application of Large Volume Acute Normovolemic Hemodilution in Cardiac Surgery

Not Applicable

Completed

• Conditions: Cardiac Surgery; Acute Normovolemic Hemodilution

• Registration Number: NCT04369443
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-28
• Study First Submitted QC: 2020-04-28
• Study First Posted: 2020-04-30
• Status Verified: 2020-05
• Study Start: 2020-05-01
• Primary Completion: 2021-01-30
• Study Completion: 2021-01-30
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• （1）18-75years old;（2）elective cardiac 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）congenital heart disease、Cardiac tumor、aortic dissection、heart transplantation（2）Low body weight（<50 kg）;（3）preoperative shock；（4）myocardial infarction within 3 months before surgery；（5）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);（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）contagious or infectious diseases;（12） patient or family members refused to participate in research;（13）refused to infusion of autologous blood or allogeneic blood products

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Volume of allogeneic blood transfusion	Through study completion，about 8 months	The mean volume of allogeneic blood transfusion

Secondary Outcome Measures

Name	Time	Method
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 renal complication	Through study completion，about 8 months	Acute kidney injury or Need renal replacement therapy
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
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

Trial Locations

Locations (1)

The Second Affiliated Hospital of Zhejiang University anesthesiology department; 🇨🇳 Hangzhou, Zhejiang, China