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Impact of Acute Normovolemic Hemodilution on Blood Viscosity

NCT ID: NCT03366753

Last Updated: 2021-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-02

Study Completion Date

2018-11-30

Brief Summary

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Acute normovolemic hemodilution (ANH) has long been employed for reducing allogenic blood transfusion for cardiac surgery, and hydroxyethyl starch has been used as an intravenous replacement fluid during ANH procedure. However, possible impact of ANH employing HES on blood viscosity and oxygen delivery have not been well investigated in patients undergoing off-pump coronary artery bypass (OPCAB) surgery .

Anesthesia is induced and maintained by using propofol-remifentanil-rocuronium in OPCAB surgery (n=21). ANH is performed by using 5 ml/kg of blood salvage and administering 5 ml/kg of balanced HES 130/0.42 (Tetraspan™) for 15 min during vascular graft harvesting. For the present study, three arterial blood samples (3 ml each) are taken before (Sample 1) and after ANH (sample 2 and 3) and they are stored in 3 tubes. Sample 3 (in tube) undergoes further 30% in-vitro dilution by adding 1-1.5 ml HES. By using a scanning capillary tube viscometer (Hemovister™), Blood viscosity at low shear rate (5/sec) of the three samples are determined. By using a formula with blood viscosity and hematocrit, tissue O2 delivery index (TODI, = hematocrit/viscosity at 5/sec) is calculated.

Detailed Description

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Conditions

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Ischemic Heart Disease Coronary Artery Disease

Keywords

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acute normovolemic hemodilution coronary artery bypass graft surgery hydroxyethyl starch blood viscosity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Acute normovolemic hemodilution consists of phlebotomy and intravascular volume resuscitation by using crystalloid/colloid in a same amount of phlebotomy
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Acute normovolemic hemodilution

acute normovolemic hemodilution by using hydroxyethyl starch

Group Type EXPERIMENTAL

acute normovolemic hemodilution

Intervention Type PROCEDURE

acute normovolemic hemodilution (ANH) is performed by using 5 ml/kg of blood salvage and intravenously administering 5 ml/kg of balanced hydroxyethystarch 130/0.42 (Tetraspan™) for 15 min

In-vitro hemodilution

Intervention Type PROCEDURE

Blood sample after ANH 5 ml/kg undergoes further 30% in-vitro dilution by adding 1-1.5 ml hydroxyethystarch 130/0.42

In-vitro hemodilution

adding additional hydroxyethyl starch for achieving further 30% dilution of whole blood sample which already underwent ANH of 4-6 ml/kg.

Group Type EXPERIMENTAL

In-vitro hemodilution

Intervention Type PROCEDURE

Blood sample after ANH 5 ml/kg undergoes further 30% in-vitro dilution by adding 1-1.5 ml hydroxyethystarch 130/0.42

Interventions

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acute normovolemic hemodilution

acute normovolemic hemodilution (ANH) is performed by using 5 ml/kg of blood salvage and intravenously administering 5 ml/kg of balanced hydroxyethystarch 130/0.42 (Tetraspan™) for 15 min

Intervention Type PROCEDURE

In-vitro hemodilution

Blood sample after ANH 5 ml/kg undergoes further 30% in-vitro dilution by adding 1-1.5 ml hydroxyethystarch 130/0.42

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* patients undergoing off-pump coronary artery bypass graft surgery

Exclusion Criteria

* Preoperative anemia
* LV ejection fraction \< 50%
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Konkuk University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Tae-Yop Kim, MD PhD

Professor of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tae-Yop Kim, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Konkuk University Medical Center

Locations

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Konkuk University Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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KUH1160102

Identifier Type: -

Identifier Source: org_study_id