Application of Large Volume Acute Normovolemic Hemodilution in Cardiac Surgery

NCT04369443 | Completed DMC

• 1 other identifier: 2020-110
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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

Conditions

Cardiac Surgery; Acute Normovolemic Hemodilution

Outcome Measures

Primary Outcomes (1)

• Volume of allogeneic blood transfusion

  The mean volume of allogeneic blood transfusion

  Through study completion，about 8 months

Secondary Outcomes (4)

• Rate of postoperative cardiac complications

  Through study completion，about 8 months

• Rate of postoperative pulmonary complications

  Through study completion，about 8 months

• Rate of postoperative renal complication

  Through study completion，about 8 months

• Other severe complication

  Through study completion，about 8 months

Study Arms (2)

MANH

NO INTERVENTION

LANH

EXPERIMENTAL

Procedure: Large volume Acute Normovolemic Hemodilution

Interventions

Large volume Acute Normovolemic Hemodilution PROCEDURE

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.

LANH

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• （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%).

You may not qualify if:

• （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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University anesthesiology department

Hangzhou, Zhejiang, 310000, China

Location

Study Officials

• Min Yan, Doctor

  The second affiliated hospital of Zhejiang University hangzhou, Zhejiang, China, 310000

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2020
• First Posted: April 30, 2020
• Study Start: May 1, 2020
• Primary Completion: January 30, 2021
• Study Completion: January 30, 2021
• Last Updated: February 8, 2023

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)