NCT02502448

Brief Summary

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 (n=40) are randomly allocated into one of two groups: in Group-ANH(n=20), 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, inter-group difference between maxiaml clot firmness of EXTEM will be determined at 10 min after ANH in Group-ANH and that at control.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

March 3, 2015

Completed
5 months until next milestone

First Posted

Study publicly available on registry

July 20, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

January 30, 2020

Status Verified

January 1, 2020

Enrollment Period

5 months

First QC Date

March 3, 2015

Last Update Submit

January 28, 2020

Conditions

Mitral RegurgitationMitral StenosisTricuspid Regurgitation

Keywords

rotational thromboelastometrycardiac surgeryacute normovolemic hemodilution

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
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 (1)

Konkuk University Medical Center

Seoul, 143-729, South Korea

Location

MeSH Terms

Conditions

Mitral Valve InsufficiencyMitral Valve StenosisTricuspid Valve Insufficiency

Interventions

Hydroxyethyl Starch Derivatives

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

StarchDietary CarbohydratesCarbohydratesGlucansPolysaccharides

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

March 3, 2015

First Posted

July 20, 2015

Study Start

January 1, 2016

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

January 30, 2020

Record last verified: 2020-01

Locations

KR(1)