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Impact of Acute Normovolemic Hemodilution on Blood Viscosity

Sponsor
Konkuk University Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT03366753
Collaborator
(none)
21
Enrollment
1
Location
2
Arms
7
Actual Duration (Months)
3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: acute normovolemic hemodilution
  • Procedure: In-vitro hemodilution
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
21 participants
Allocation:
Non-Randomized
Intervention Model:
Factorial Assignment
Intervention Model Description:
Acute normovolemic hemodilution consists of phlebotomy and intravascular volume resuscitation by using crystalloid/colloid in a same amount of phlebotomyAcute normovolemic hemodilution consists of phlebotomy and intravascular volume resuscitation by using crystalloid/colloid in a same amount of phlebotomy
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Impact of Intravascular Fluid Resuscitation for Acute Normovolemic Hemodilution on Blood Viscosity and Oxygen Delivery in Coronary Artery Bypass Graft Surgery
Actual Study Start Date :
May 2, 2018
Actual Primary Completion Date :
Nov 30, 2018
Actual Study Completion Date :
Nov 30, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

  1. 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

  2. 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)

  3. 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,

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • patients undergoing off-pump coronary artery bypass graft surgery
Exclusion Criteria:

  • Preoperative anemia

  • LV ejection fraction < 50%

Contacts and Locations

Locations

Site City State Country Postal Code
1 Konkuk University Medical Center Seoul Korea, Republic of 143-729

Sponsors and Collaborators

  • Konkuk University Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tae-Yop Kim, MD PhD, Professor of Anesthesiology, Konkuk University Medical Center
ClinicalTrials.gov Identifier:
NCT03366753
Other Study ID Numbers:
  • KUH1160102
First Posted:
Dec 8, 2017
Last Update Posted:
Dec 29, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Tae-Yop Kim, MD PhD, Professor of Anesthesiology, Konkuk University Medical Center
acute normovolemic hemodilution
coronary artery bypass graft surgery
hydroxyethyl starch
blood viscosity
Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases

Study Results

No Results Posted as of Dec 29, 2021