Impact of Acute Normovolemic Hemodilution on Blood Viscosity
Primary Purpose
Ischemic Heart Disease, Coronary Artery Disease
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
acute normovolemic hemodilution
In-vitro hemodilution
Sponsored by
About this trial
This is an interventional supportive care trial for Ischemic Heart Disease focused on measuring acute normovolemic hemodilution, coronary artery bypass graft surgery, hydroxyethyl starch, blood viscosity
Eligibility Criteria
Inclusion Criteria:
- patients undergoing off-pump coronary artery bypass graft surgery
Exclusion Criteria:
- Preoperative anemia
- LV ejection fraction < 50%
Sites / Locations
- Konkuk University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Acute normovolemic hemodilution
In-vitro hemodilution
Arm Description
acute normovolemic hemodilution by using hydroxyethyl starch
adding additional hydroxyethyl starch for achieving further 30% dilution of whole blood sample which already underwent ANH of 4-6 ml/kg.
Outcomes
Primary Outcome Measures
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
hematocrit/blood viscosity at 5/sec
oxygen delivery index calculated with a formula (= hematocrit/blood viscosity)
Secondary Outcome Measures
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
Hematocrit/viscosity at shear rate 300/sec
oxygen delivery index calculated with a formula (= hematocrit/blood viscosity)
Coagulation profiles in ROTEM
clot formation time in extem, MCF in extemA5 in fibtem,
Full Information
NCT ID
NCT03366753
First Posted
November 28, 2017
Last Updated
December 8, 2021
Sponsor
Konkuk University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03366753
Brief Title
Impact of Acute Normovolemic Hemodilution on Blood Viscosity
Official Title
Impact of Intravascular Fluid Resuscitation for Acute Normovolemic Hemodilution on Blood Viscosity and Oxygen Delivery in Coronary Artery Bypass Graft Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
May 2, 2018 (Actual)
Primary Completion Date
November 30, 2018 (Actual)
Study Completion Date
November 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Konkuk University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Heart Disease, Coronary Artery Disease
Keywords
acute normovolemic hemodilution, coronary artery bypass graft surgery, hydroxyethyl starch, blood viscosity
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Acute normovolemic hemodilution consists of phlebotomy and intravascular volume resuscitation by using crystalloid/colloid in a same amount of phlebotomy
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acute normovolemic hemodilution
Arm Type
Experimental
Arm Description
acute normovolemic hemodilution by using hydroxyethyl starch
Arm Title
In-vitro hemodilution
Arm Type
Experimental
Arm Description
adding additional hydroxyethyl starch for achieving further 30% dilution of whole blood sample which already underwent ANH of 4-6 ml/kg.
Intervention Type
Procedure
Intervention Name(s)
acute normovolemic hemodilution
Intervention Description
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
Intervention Name(s)
In-vitro hemodilution
Intervention Description
Blood sample after ANH 5 ml/kg undergoes further 30% in-vitro dilution by adding 1-1.5 ml hydroxyethystarch 130/0.42
Primary Outcome Measure Information:
Title
blood viscosity at shear rate 5/sec
Description
By using a scanning capillary tube viscometer (Hemovister™), Blood viscosity at shear rate 5/sec of the three samples are determined
Time Frame
5 min after acute normovoelmic hemodilution, 5 min after in-vitro dilution
Title
hematocrit/blood viscosity at 5/sec
Description
oxygen delivery index calculated with a formula (= hematocrit/blood viscosity)
Time Frame
5 min after acute normovoelmic hemodilution, 5 min after in-vitro dilution
Secondary Outcome Measure Information:
Title
blood viscosity at shear rate 300/sec
Description
By using a scanning capillary tube viscometer (Hemovister™), Blood viscosity at shear rate 300/sec of the three samples are determined
Time Frame
5 min after acute normovoelmic hemodilution, 5 min after in-vitro dilution
Title
Hematocrit/viscosity at shear rate 300/sec
Description
oxygen delivery index calculated with a formula (= hematocrit/blood viscosity)
Time Frame
5 min after acute normovoelmic hemodilution, 5 min after in-vitro dilution
Title
Coagulation profiles in ROTEM
Description
clot formation time in extem, MCF in extemA5 in fibtem,
Time Frame
5 min after acute normovoelmic hemodilution, 5 min after in-vitro dilution
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients undergoing off-pump coronary artery bypass graft surgery
Exclusion Criteria:
Preoperative anemia
LV ejection fraction < 50%
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tae-Yop Kim, MD PhD
Organizational Affiliation
Konkuk University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Konkuk University Medical Center
City
Seoul
ZIP/Postal Code
143-729
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
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Impact of Acute Normovolemic Hemodilution on Blood Viscosity
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