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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04369443
Other study ID # 2020-110
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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