Impact of Acute Normovolemic Hemodilution on Blood Viscosity

Impact of Intravascular Fluid Resuscitation for Acute Normovolemic Hemodilution on Blood Viscosity and Oxygen Delivery in Coronary Artery Bypass Graft Surgery

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Ischemic Heart Disease
• Intervention / Treatment: Procedure: acute normovolemic hemodilution; Procedure: In-vitro hemodilution

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 143-729
    • Konkuk University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients undergoing off-pump coronary artery bypass graft surgery

Exclusion Criteria:

• Preoperative anemia
• LV ejection fraction < 50%

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acute normovolemic hemodilution; acute normovolemic hemodilution by using hydroxyethyl starch	Procedure: 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; 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
Experimental: 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.	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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Konkuk University Medical Center
• Investigators: Principal Investigator: Tae-Yop Kim, MD PhD, Konkuk University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2018
• Primary Completion (Actual): November 30, 2018
• Study Completion (Actual): November 30, 2018

Study Registration Dates

• First Submitted: November 28, 2017
• First Submitted That Met QC Criteria: December 3, 2017
• First Posted (Actual): December 8, 2017

Study Record Updates

• Last Update Posted (Actual): December 29, 2021
• Last Update Submitted That Met QC Criteria: December 8, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: coronary artery bypass graft surgery; acute normovolemic hemodilution; blood viscosity; hydroxyethyl starch
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia
• Other Study ID Numbers: KUH1160102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No