Ischemic Heart DiseaseNCT03366753
Impact of Acute Normovolemic Hemodilution on Blood Viscosity
A study testing acute normovolemic hemodilution and In-vitro hemodilution in people with Ischemic Heart Disease and Coronary Artery Disease, run by Konkuk University Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ischemic Heart Disease, Coronary Artery Disease
- What is being tested?
- acute normovolemic hemodilution and In-vitro hemodilution
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 May 2018to 30 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients undergoing off-pump coronary artery bypass graft surgery
Who cannot join
- Preoperative anemia
- LV ejection fraction < 50%
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Ischemic Heart Disease, Coronary Artery Disease
- Being tested
- acute normovolemic hemodilution, In-vitro hemodilution
- Keywords
- acute normovolemic hemodilution, coronary artery bypass graft surgery, hydroxyethyl starch, blood viscosity
- Medical subject headings
- Myocardial Ischemia, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acute normovolemic hemodilutionProcedure or surgery
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
In-vitro hemodilutionProcedure or surgery
Blood sample after ANH 5 ml/kg undergoes further 30% in-vitro dilution by adding 1-1.5 ml hydroxyethystarch 130/0.42
| Study group | Role | What they receive |
|---|---|---|
| Acute normovolemic hemodilution | Experimental | acute normovolemic hemodilution by using hydroxyethyl starch Receives: 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. Receives: Procedure: In-vitro hemodilution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 5 min after acute normovoelmic hemodilution, 5 min after in-vitro dilution
Secondary outcomes (3)
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
Measured: 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)
Measured: 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,
Measured: 5 min after acute normovoelmic hemodilution, 5 min after in-vitro dilution
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2017
- Study start2 May 2018
- Primary completion30 Nov 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Factorial
- 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)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konkuk University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tae-Yop Kim, MD PhD, Konkuk University Medical Center
- Investigators
- Tae-Yop Kim, MD PhD, Principal investigator, Konkuk University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03366753
- Sponsor's protocol ID
- KUH1160102
- Status last verified
- Dec 2021
- First submitted
- 28 Nov 2017
- Last updated
- 29 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Intravascular Fluid Resuscitation for Acute Normovolemic Hemodilution on Blood Viscosity and Oxygen Delivery in Coronary Artery Bypass Graft Surgery
- ClinicalTrials.gov ID
- NCT03366753
- Acronym / sponsor ID
- KUH1160102
- Conditions
- Ischemic Heart Disease, Coronary Artery Disease
- Keywords
- acute normovolemic hemodilution, coronary artery bypass graft surgery, hydroxyethyl starch, blood viscosity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Konkuk University Medical CenterUniversity, hospital or other
- Study start
- 2 May 2018 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 8 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Acute normovolemic hemodilution consists of phlebotomy and intravascular volume resuscitation by using crystalloid/colloid in a same amount of phlebotomy
| Arm | Type | Receives |
|---|---|---|
| Acute normovolemic hemodilution | Experimental | Procedure: acute normovolemic hemodilution, Procedure: In-vitro hemodilutionacute normovolemic hemodilution by using hydroxyethyl starch |
| In-vitro hemodilution | Experimental | Procedure: In-vitro hemodilutionadding additional hydroxyethyl starch for achieving further 30% dilution of whole blood sample which already underwent ANH of 4-6 ml/kg. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing off-pump coronary artery bypass graft surgery
Key exclusion criteria (2 listed)
- Preoperative anemia
- LV ejection fraction < 50%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acute normovolemic hemodilutionacute 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 or surgery | Acute normovolemic hemodilution |
| In-vitro hemodilutionBlood sample after ANH 5 ml/kg undergoes further 30% in-vitro dilution by adding 1-1.5 ml hydroxyethystarch 130/0.42 | Procedure or surgery | Acute normovolemic hemodilution, In-vitro hemodilution |
Primary outcome
blood viscosity at shear rate 5/sec
Time frame: 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
Time frame: 5 min after acute normovoelmic hemodilution, 5 min after in-vitro dilution
oxygen delivery index calculated with a formula (= hematocrit/blood viscosity)
3 secondary outcomes
blood viscosity at shear rate 300/sec
Time frame: 5 min after acute normovoelmic hemodilution, 5 min after in-vitro dilution
Hematocrit/viscosity at shear rate 300/sec
Time frame: 5 min after acute normovoelmic hemodilution, 5 min after in-vitro dilution
Coagulation profiles in ROTEM
Time frame: 5 min after acute normovoelmic hemodilution, 5 min after in-vitro dilution
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tae-Yop Kim, MD PhD principal investigator
Konkuk University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acute normovolemic hemodilution and In-vitro hemodilution in people with Ischemic Heart Disease and Coronary Artery Disease, run by Konkuk University Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood viscosity at shear rate 5/sec (time frame: 5 min after acute normovoelmic hemodilution, 5 min after in-vitro dilution). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2021.