Application of Large Volume Acute Normovolemic Hemodilution in Cardiac Valve Surgery

NCT03933917 | Completed DMC

• 1 other identifier: 2019-056
• Study Type: interventional
• Target: 74
• 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 Valve Surgery

Outcome Measures

Primary Outcomes (3)

• Enrollment rate of subjects

  The percentage of patients who completed the study

  Through study completion，about 8 months

• Completion rate of acute normovolemic hemodilution

  The percentage of patients who complete large volume of acute normovolemic hemodilution

  Through study completion，about 8 months

• Additional blood transfusion beyond transfusion protocol

  Nonstandard blood transfusion

  Through study completion，about 8 months

Secondary Outcomes (6)

• Rate of perioperative blood transfusion

  Through study completion，about 8 months

• 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 neurological complication

  Through study completion，about 8 months

• Rate of postoperative renal complication

  Through study completion，about 8 months

Study Arms (1)

Large Volume Acute Normovolemic Hemodilution

EXPERIMENTAL

All the participants will undergo Large Volume Acute Normovolemic Hemodilution.

Procedure: Acute Normovolemic Hemodilution

Interventions

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.

Large Volume Acute Normovolemic Hemodilution

Eligibility Criteria

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

You may qualify if:

• Audlt patients ( ≥ 18 years old);
• elective valve surgery under cardiopulmonary bypass;
• Preoperative hemoglobin (Hb) ≥ 12g/dl; (4) Transfusion Risk Understanding Scoring Tool (TRUST) ≥ 2 (possibility of blood transfusion ≥40%).

You may not qualify if:

• （1）Low body weight (male: \<50 kg;Female: \< 45kg);（2）preoperative shock；（3）myocardial infarction within 3 months before surgery；（4）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);（5）uncontrolled hypertension;（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）preoperative preparation platelet;（12） contagious or infectious diseases;（13） patient or family members refused to participate in research;（14）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

Hangzhou, Zhejiang, 310000, China

Location

Study Officials

• Min Yan, Doctor

  Zhejiang University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2019
• First Posted: May 1, 2019
• Study Start: May 27, 2019
• Primary Completion: April 22, 2020
• Study Completion: April 22, 2020
• Last Updated: May 12, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)