Application of Large Volume Acute Normovolemic Hemodilution in Cardiac Valve Surgery

Not Applicable

Completed

• Conditions: Cardiac Valve Surgery
• Interventions: Procedure: Acute Normovolemic Hemodilution

• Registration Number: NCT03933917
• 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: 2019-04-24
• Study First Submitted QC: 2019-04-30
• Study First Posted: 2019-05-01
• Study Start: 2019-05-27
• Primary Completion: 2020-04-22
• Study Completion: 2020-04-22
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-09
• Last Update Posted: 2020-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Large Volume Acute Normovolemic Hemodilution	Acute Normovolemic Hemodilution	All the participants will undergo Large Volume Acute Normovolemic Hemodilution.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 perioperative blood transfusion	Through study completion，about 8 months	The percentage of red blood, fresh frozen plasma and platelet transfusion
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
Rate of postoperative neurological complication	Through study completion，about 8 months	Including cerebral hemorrhage, cerebral infarction according to physical and laboratory examination
Rate of postoperative renal complication	Through study completion，about 8 months	Need renal replacement therapy

Trial Locations

Locations (1)

The second affiliated hospital of Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China