Impact of Acute Normovolemic Hemodilution on Blood Viscosity

NCT03366753 | Completed DMC

• 1 other identifier: KUH1160102
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Heart Disease; Coronary Artery Disease

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• blood viscosity at shear rate 300/sec

  5 min after acute normovoelmic hemodilution, 5 min after in-vitro dilution

• Hematocrit/viscosity at shear rate 300/sec

  5 min after acute normovoelmic hemodilution, 5 min after in-vitro dilution

• Coagulation profiles in ROTEM

  5 min after acute normovoelmic hemodilution, 5 min after in-vitro dilution

Study Arms (2)

Acute normovolemic hemodilution

EXPERIMENTAL

acute normovolemic hemodilution by using hydroxyethyl starch

Procedure: acute normovolemic hemodilution; Procedure: In-vitro hemodilution

In-vitro hemodilution

EXPERIMENTAL

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

Interventions

acute normovolemic hemodilution 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

Acute normovolemic hemodilution

In-vitro hemodilution PROCEDURE

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

Acute normovolemic hemodilution; In-vitro hemodilution

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patients undergoing off-pump coronary artery bypass graft surgery

You may not qualify if:

• Preoperative anemia
• LV ejection fraction \< 50%

Sponsors & Collaborators

• Konkuk University Medical Center: lead

Study Sites (1)

Konkuk University Medical Center

Seoul, 143-729, South Korea

Location

MeSH Terms

Conditions

Myocardial Ischemia; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Tae-Yop Kim, MD PhD

  Konkuk University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Model Details: Acute normovolemic hemodilution consists of phlebotomy and intravascular volume resuscitation by using crystalloid/colloid in a same amount of phlebotomy

Study Record Dates

• First Submitted: November 28, 2017
• First Posted: December 8, 2017
• Study Start: May 2, 2018
• Primary Completion: November 30, 2018
• Study Completion: November 30, 2018
• Last Updated: December 29, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)