Impact of Acute Normovolemic Hemodilution on Blood Viscosity

Not Applicable

Completed

• Conditions: Coronary Artery Disease; Ischemic Heart Disease
• Interventions: Procedure: acute normovolemic hemodilution; Procedure: In-vitro hemodilution

• Registration Number: NCT03366753
• Lead Sponsor: Konkuk University Medical Center

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2017-11-28
• Study First Submitted QC: 2017-12-03
• Study First Posted: 2017-12-08
• Study Start: 2018-05-02
• Primary Completion: 2018-11-30
• Study Completion: 2018-11-30
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-08
• Last Update Posted: 2021-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• patients undergoing off-pump coronary artery bypass graft surgery

Exclusion Criteria

• Preoperative anemia
• LV ejection fraction < 50%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Acute normovolemic hemodilution	acute normovolemic hemodilution	acute normovolemic hemodilution by using hydroxyethyl starch
Acute normovolemic hemodilution	In-vitro hemodilution	acute normovolemic hemodilution by using hydroxyethyl starch
In-vitro hemodilution	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.

Primary Outcome Measures

Name	Time	Method
blood viscosity at shear rate 5/sec	5 min after acute normovoelmic hemodilution, 5 min after in-vitro dilution	By using a scanning capillary tube viscometer (Hemovister™), Blood viscosity at shear rate 5/sec of the three samples are determined
hematocrit/blood viscosity at 5/sec	5 min after acute normovoelmic hemodilution, 5 min after in-vitro dilution	oxygen delivery index calculated with a formula (= hematocrit/blood viscosity)

Secondary Outcome Measures

Name	Time	Method
blood viscosity at shear rate 300/sec	5 min after acute normovoelmic hemodilution, 5 min after in-vitro dilution	By using a scanning capillary tube viscometer (Hemovister™), Blood viscosity at shear rate 300/sec of the three samples are determined
Coagulation profiles in ROTEM	5 min after acute normovoelmic hemodilution, 5 min after in-vitro dilution	clot formation time in extem, MCF in extemA5 in fibtem,
Hematocrit/viscosity at shear rate 300/sec	5 min after acute normovoelmic hemodilution, 5 min after in-vitro dilution	oxygen delivery index calculated with a formula (= hematocrit/blood viscosity)

Trial Locations

Locations (1)

Konkuk University Medical Center; 🇰🇷 Seoul, Korea, Republic of