Application of Large Volume Acute Normovolemic Hemodilution in Cardiac Valve Surgery

Effect of Large Volume Acute Normovolemic Hemodilution on Perioperative Blood Transfusion and Outcomes in Cardiac Valve 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

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Audlt patients ( ≥ 18 years old);
  2. elective valve 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)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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Large Volume Acute Normovolemic Hemodilution
All the participants will undergo 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
Enrollment rate of subjects
Time Frame: Through study completion,about 8 months
The percentage of patients who completed the study
Through study completion,about 8 months
Completion rate of acute normovolemic hemodilution
Time Frame: Through study completion,about 8 months
The percentage of patients who complete large volume of acute normovolemic hemodilution
Through study completion,about 8 months
Additional blood transfusion beyond transfusion protocol
Time Frame: Through study completion,about 8 months
Nonstandard blood transfusion
Through study completion,about 8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of perioperative blood transfusion
Time Frame: Through study completion,about 8 months
The percentage of red blood, fresh frozen plasma and platelet transfusion
Through study completion,about 8 months
Rate of postoperative cardiac complications
Time Frame: Through study completion,about 8 months
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
Time Frame: Through study completion,about 8 months
Including moderate and massive pleural effusion, respiratory failure, re-intubation according to physical and laboratory examination
Through study completion,about 8 months
Rate of postoperative neurological complication
Time Frame: Through study completion,about 8 months
Including cerebral hemorrhage, cerebral infarction according to physical and laboratory examination
Through study completion,about 8 months
Rate of postoperative renal complication
Time Frame: Through study completion,about 8 months
Need renal replacement therapy
Through study completion,about 8 months
Other severe complication
Time Frame: Through study completion,about 8 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 27, 2019

Primary Completion (Actual)

April 22, 2020

Study Completion (Actual)

April 22, 2020

Study Registration Dates

First Submitted

April 24, 2019

First Submitted That Met QC Criteria

April 30, 2019

First Posted (Actual)

May 1, 2019

Study Record Updates

Last Update Posted (Actual)

May 12, 2020

Last Update Submitted That Met QC Criteria

May 9, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 2019-056

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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