Application of Large Volume Acute Normovolemic Hemodilution in Cardiac Surgery

Cardiac Surgery Clinical Trial

Official title:

Application of Large Volume Acute Normovolemic Hemodilution in Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04369443
• Other study ID #: 2020-110
• Status: Completed
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: January 30, 2021

Study information

• Verified date: May 2020
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: January 30, 2021
• Est. primary completion date: January 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Normovolemic Hemodilution
• Cardiac Surgery

Intervention

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.

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Zhejiang University anesthesiology department	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Volume of allogeneic blood transfusion	The mean volume of allogeneic blood transfusion	Through study completion,about 8 months
Secondary	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
Secondary	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
Secondary	Rate of postoperative renal complication	Acute kidney injury or Need renal replacement therapy	Through study completion,about 8 months
Secondary	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