Clinical trial NCT04369443: Application of Large Volume Acute Normovolemic Hemodilution in Cardiac Surgery
Official title: Application of Large Volume Acute Normovolemic Hemodilution in Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Surgery
Acute Normovolemic Hemodilution
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2020-04-30
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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）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

Primary outcomes:
measure: Volume of allogeneic blood transfusion
timeFrame: Through study completion，about 8 months
Secondary outcomes:
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 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 anesthesiology department
state: Zhejiang
Study officials:
affiliation: The second affiliated hospital of Zhejiang University hangzhou, Zhejiang, China, 310000
name: Min Yan, Doctor
role: STUDY_CHAIR
References: