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Mild ANH on Pre-bypass Coagulation Function During Cardiac Surgery

NCT06664320 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-10-31

No results posted yet for this study

Summary

The impact of acute normovolemic hemodilution (ANH) using hydroxyethyl starch before initiating cardiopulmonary bypass (CPB) on whole blood viscoelastic profile after CPB has not been well established. Patients undergoing cardiac surgery employing moderate hypothermic CPB are randomly allocated into one of two groups: in Group-ANH, ANH is applied by using a balanced hydroxyethyl starch (HES 130/0.6); and in Group-C, ANH is not applied. After weaning from CPB, intergroup differences of INTEM, EXTEM, FIBTEM, and APTEM profiles are analyzed. As a primary outcome, the inter-group differences between maximal clot firmness of EXTEM will be determined at 10 min after ANH in Group-ANH and that at control.

Conditions

  • Mitral Regurgitation
  • Mitral Stenosis
  • Tricuspid Regurgitation

Interventions

PROCEDURE

Acute normovolemic hemodilution (ANH)

applying acute normovolemic hemodilution (ANH) by using HES 130/0.4 of 5 ml/kg before the initiation of cardiopulmonary bypass

DRUG

hydroxyethyl starch (HES 130/0.6)

hydroxyethyl starch (HES 130/0.6)

Sponsors & Collaborators

  • Konkuk University Medical Center

    lead OTHER

Principal Investigators

  • Tae-Yop Kim, MD, PhD · Konkuk University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-28
Primary Completion
2025-03-30
Completion
2025-04-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06664320 on ClinicalTrials.gov