Application of Large Volume Acute Normovolemic Hemodilution in Cardiac Surgery

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 Overview

• Status: Completed
• Conditions: Cardiac Surgery; Acute Normovolemic Hemodilution
• Intervention / Treatment: Procedure: Large volume Acute Normovolemic Hemodilution

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • The Second Affiliated Hospital of Zhejiang University anesthesiology department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: MANH
EXPERIMENTAL: LANH	Procedure: Large volume Acute Normovolemic Hemodilution; Following induction of anesthesia, the volume of blood to be removed during Acute Normovolemic Hemodilution was calculated using an established formula:V=Weight（Kg）×12-15（mL/Kg）;Blood to be removed was capped at： Vmax=EVB×(Hi-Hf)/Hav（EBV= estimated blood volume （male:70mL/Kg，female:65mL/Kg）；Hi= initial hemoglobin ；Hf=target Hb（ 10g/dL ）；Hav= the average of the initial and minimal allowable hemoglobin）.Ensure the volume of removed blood does not exceed the upper limit and Hb ≥10g/dL after blood removed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volume of allogeneic blood transfusion	The mean volume of allogeneic blood transfusion	Through study completion，about 8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of postoperative cardiac complications	Including myocardial infarction, heart failure, low cardiac output, pericardial tamponade, severe arrhythmia according to physical and laboratory examination	Through study completion，about 8 months
Rate of postoperative pulmonary complications	Including moderate and massive pleural effusion, respiratory failure, re-intubation according to physical and laboratory examination	Through study completion，about 8 months
Other severe complication	Including re-operation, re-admission of intensive care unit, multiple organ dysfunction, all cause death according to physical and laboratory examination and medical record	Through study completion，about 8 months
Rate of postoperative renal complication	Acute kidney injury or Need renal replacement therapy	Through study completion，about 8 months

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Study Chair: Min Yan, Doctor, The second affiliated hospital of Zhejiang University hangzhou, Zhejiang, China, 310000

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2020
• Primary Completion (ACTUAL): January 30, 2021
• Study Completion (ACTUAL): January 30, 2021

Study Registration Dates

• First Submitted: April 28, 2020
• First Submitted That Met QC Criteria: April 28, 2020
• First Posted (ACTUAL): April 30, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2020-110

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No