NCT06664320

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

October 28, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 29, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

October 31, 2024

Status Verified

October 1, 2024

Enrollment Period

5 months

First QC Date

October 27, 2024

Last Update Submit

October 30, 2024

Conditions

Mitral RegurgitationMitral StenosisTricuspid Regurgitation

Keywords

rotational thromboelastometrycardiac surgeryacute normovolemic hemodilutionhemodilutioncoagulation

Outcome Measures

Primary Outcomes (1)

  • Maximal clot firmness of EXTEM

    Maxiaml clot firmess (MCF) of EXTEM of rotational thromboleastometry

    10 min after completion of acute normovolemic hemodilution (ANH)

Secondary Outcomes (2)

  • Clot formation time of EXTEM

    10 min after completion of acute normovolemic hemodilution

  • A10 of FIBTEM

    10 min after completion of acute normovolemic hemodilution

Study Arms (2)

Control group

NO INTERVENTION

patients undergoing cardiac surgery supposed not to get aucte normovolemic hemodilution (ANH) before CPB

Acute normovolemic hemodilution group

ACTIVE COMPARATOR

patients undergoing cardiac surgery supposed to get aucte normovolemic hemodilution (ANH) before CPB

Procedure: Acute normovolemic hemodilution (ANH)Drug: hydroxyethyl starch (HES 130/0.6)

Interventions

Acute normovolemic hemodilution (ANH)PROCEDURE

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

Acute normovolemic hemodilution group
hydroxyethyl starch (HES 130/0.6)DRUG

hydroxyethyl starch (HES 130/0.6)

Acute normovolemic hemodilution group

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients undergoing cardiac surgery with cardiopulmonary bypass who signed written informed consent

You may not qualify if:

  • preoperative renal failure requiring reran replacement therapy
  • preoperative liver disease
  • preoperative low cardiac output (EF \< 50%)
  • Preoperative IABP application, Atrial fibrillation, Pacemaker
  • contraindication for applying TEE
  • intraoperative withdrawal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Konkuk University Medical Center

Seoul, Seoul, 05030, South Korea

Location

Konkuk University Medical Center

Seoul, 143-729, South Korea

Location

MeSH Terms

Conditions

Mitral Valve InsufficiencyMitral Valve StenosisTricuspid Valve InsufficiencyThrombosis

Interventions

Hydroxyethyl Starch Derivatives

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular DiseasesEmbolism and ThrombosisVascular Diseases

Intervention Hierarchy (Ancestors)

StarchDietary CarbohydratesCarbohydratesGlucansPolysaccharides

Study Officials

  • Tae-Yop Kim, MD, PhD

    Konkuk University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tae-Yop Kim, MD, PhD

CONTACT

+82-2-2030-5445taeyop@gmail.com

Wooseul Lee, Bachelor

CONTACT

+82-2-2030-5448wslee.kku@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesiology

Study Record Dates

First Submitted

October 27, 2024

First Posted

October 29, 2024

Study Start

October 28, 2024

Primary Completion

March 30, 2025

Study Completion

April 30, 2025

Last Updated

October 31, 2024

Record last verified: 2024-10

Locations

KR(2)