Mitral RegurgitationNCT02502448
Acute Normovolemic Hemodilution on ROTEM in Cardiac Surgery
A study testing Acute normovolemic hemodilution (ANH) and hydroxyethyl starch (HES 130/0.6) in people with Mitral Regurgitation and Mitral Stenosis, run by Konkuk University Medical Center at 1 site in South Korea.
Trial summary
Impact of acute normovolemic hemodilution (ANH) using hydroxyethyl starch before initiating cardiopulmonary bypass (CPB) on whole blood viscoelastic profile after CPB has not been well established. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Mitral Regurgitation, Mitral Stenosis, Tricuspid Regurgitation
- What is being tested?
- Acute normovolemic hemodilution (ANH) and hydroxyethyl starch (HES 130/0.6)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2016to Jun 2016
- 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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing cardiac surgery with cardiopulmonary bypass who signed written informed consent
Who cannot join
- preoperative renal failure requiring reran replacement therapy
- preoperative liver disease
- preoperative low cardiac output (EF < 50%)
- Preoperative IABP application, Atrial fibrillation, Pacemaker,
- contraindication for applying TEE
- intraoperative withdrawal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Acute Normovolemic Hemodilution on Whole Blood Coagulation Profile During Post-cardiopulmonary Bypass in Cardiac Surgery: Rotational Thromboelastometry Study
Impact of acute normovolemic hemodilution (ANH) using hydroxyethyl starch before initiating cardiopulmonary bypass (CPB) on whole blood viscoelastic profile after CPB has not been well established.
Patients undergoing cardiac surgery employing moderate hypothermic CPB (n=40) are randomly allocated into one of two groups: in Group-ANH(n=20), ANH is applied by using a balanced hydroxyethyl starch (HES 130/0.6); and in Group-C, ANH is not applied.
Read more
After weaning from CPB, intergroup differences of INTEM, EXTEM, FIBTEM and APTEM profiles are analyzed.
As a primary outcome, inter-group difference between maxiaml clot firmness of EXTEM will be determined at 10 min after ANH in Group-ANH and that at control.
Read the detailed description
Background: Impact of acute normovolemic hemodilution (ANH) using hydroxyethyl starch before initiating cardiopulmonary bypass (CPB) on whole blood viscoelastic profile after CPB has not been well established.
Method: Patients undergoing cardiac surgery employing moderate hypothermic CPB (n=40) are randomly allocated into one of two groups: in Group-ANH(n=20), ANH is applied by using a balanced hydroxyethyl starch (HES 130/0.6); and in Group-C ANH is not applied.
Intergroup differences of INTEM, EXTEM, FIBTEM and APTEM profiles are analyzed. after anesthesia induction (control) and after weaning form CPB and protamine neutralization (after-CPB) in both groups. In Group-ANH, those are determined after ANH (after-ANH).
As a primary outcome, inter-group difference between maxiaml clot firmness of EXTEM is determined at 10 min after ANH in Group-ANH and that at control.
As secondary outcomes, intergroup differences of Hematocrit (Hct), Na+, K+, HCO3-, Ca2+, osmolarity, s-Cr are determined Intergroup difference of data at T2 are performed.
- Being tested
- Acute normovolemic hemodilution (ANH), hydroxyethyl starch (HES 130/0.6)
- Keywords
- rotational thromboelastometry, cardiac surgery, acute normovolemic hemodilution
- Medical subject headings
- Mitral Valve Insufficiency, Mitral Valve Stenosis, Tricuspid Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute normovolemic hemodilution (ANH)Procedure or surgery
applying acute normovolemic hemodilution (ANH) by using HES 130/0.4 of 5 ml/kg before the initiation of cardiopulmonary bypass
hydroxyethyl starch (HES 130/0.6)Drug
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | patients undergoing cardiac surgery supposed not to get aucte normovolemic hemodilution (ANH) before CPB |
| Acute normovolemic hemodilution group | Active comparator | patients undergoing cardiac surgery supposed to get aucte normovolemic hemodilution (ANH) before CPB Receives: Procedure: Acute normovolemic hemodilution (ANH); Drug: hydroxyethyl starch (HES 130/0.6) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal clot firmness of EXTEM
Maxiaml clot firmess (MCF) of EXTEM of rotational thromboleastometry
Measured: 10 min after completion of acute normovolemic hemodilution (ANH)
Secondary outcomes (2)
Clot formation time of EXTEM
Clot formation time of EXTEM of rotational thromboleastometry
Measured: 10 min after completion of acute normovolemic hemodilution
A10 of FIBTEM
A10 of FIBTEM of rotational thromboelastometry
Measured: 10 min after completion of acute normovolemic hemodilution
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2015 (estimated)
- Study startJan 2016
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral RegurgitationStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02502448
- Sponsor's protocol ID
- KUH1160030
- Status last verified
- Jan 2020
- First submitted
- 3 Mar 2015
- Last updated
- 30 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Acute Normovolemic Hemodilution on Whole Blood Coagulation Profile During Post-cardiopulmonary Bypass in Cardiac Surgery: Rotational Thromboelastometry Study
- ClinicalTrials.gov ID
- NCT02502448
- Acronym / sponsor ID
- KUH1160030
- Keywords
- rotational thromboelastometry, cardiac surgery, acute normovolemic hemodilution
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Konkuk University Medical CenterUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 20 Jul 2015 (estimated)
- 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.
Impact of acute normovolemic hemodilution (ANH) using hydroxyethyl starch before initiating cardiopulmonary bypass (CPB) on whole blood viscoelastic profile after CPB has not been well established.
Patients undergoing cardiac surgery employing moderate hypothermic CPB (n=40) are randomly allocated into one of two groups: in Group-ANH(n=20), ANH is applied by using a balanced hydroxyethyl starch (HES 130/0.6); and in Group-C, ANH is not applied.
After weaning from CPB, intergroup differences of INTEM, EXTEM, FIBTEM and APTEM profiles are analyzed.
As a primary outcome, inter-group difference between maxiaml clot firmness of EXTEM will be determined at 10 min after ANH in Group-ANH and that at control.
Detailed description
Background: Impact of acute normovolemic hemodilution (ANH) using hydroxyethyl starch before initiating cardiopulmonary bypass (CPB) on whole blood viscoelastic profile after CPB has not been well established.
Method: Patients undergoing cardiac surgery employing moderate hypothermic CPB (n=40) are randomly allocated into one of two groups: in Group-ANH(n=20), ANH is applied by using a balanced hydroxyethyl starch (HES 130/0.6); and in Group-C ANH is not applied.
Intergroup differences of INTEM, EXTEM, FIBTEM and APTEM profiles are analyzed. after anesthesia induction (control) and after weaning form CPB and protamine neutralization (after-CPB) in both groups. In Group-ANH, those are determined after ANH (after-ANH).
As a primary outcome, inter-group difference between maxiaml clot firmness of EXTEM is determined at 10 min after ANH in Group-ANH and that at control.
As secondary outcomes, intergroup differences of Hematocrit (Hct), Na+, K+, HCO3-, Ca2+, osmolarity, s-Cr are determined Intergroup difference of data at T2 are performed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –patients undergoing cardiac surgery supposed not to get aucte normovolemic hemodilution (ANH) before CPB |
| Acute normovolemic hemodilution group | Active comparator | Procedure: Acute normovolemic hemodilution (ANH), Drug: hydroxyethyl starch (HES 130/0.6)patients undergoing cardiac surgery supposed to get aucte normovolemic hemodilution (ANH) before CPB |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing cardiac surgery with cardiopulmonary bypass who signed written informed consent
Key exclusion criteria (6 listed)
- preoperative renal failure requiring reran replacement therapy
- preoperative liver disease
- preoperative low cardiac output (EF < 50%)
- Preoperative IABP application, Atrial fibrillation, Pacemaker,
- contraindication for applying TEE
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 hemodilution (ANH)applying acute normovolemic hemodilution (ANH) by using HES 130/0.4 of 5 ml/kg before the initiation of cardiopulmonary bypass | Procedure or surgery | Acute normovolemic hemodilution group |
| hydroxyethyl starch (HES 130/0.6) | Drug | Acute normovolemic hemodilution group |
Primary outcome
Maximal clot firmness of EXTEM
Time frame: 10 min after completion of acute normovolemic hemodilution (ANH)
Maxiaml clot firmess (MCF) of EXTEM of rotational thromboleastometry
2 secondary outcomes
Clot formation time of EXTEM
Time frame: 10 min after completion of acute normovolemic hemodilution
A10 of FIBTEM
Time frame: 10 min after completion of acute normovolemic hemodilution
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 30 Jan 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 (ANH) and hydroxyethyl starch (HES 130/0.6) in people with Mitral Regurgitation and Mitral Stenosis, 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 6 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 30 Jan 2020. 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?
Maximal clot firmness of EXTEM (time frame: 10 min after completion of acute normovolemic hemodilution (ANH)). 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 30 Jan 2020.