Mitral RegurgitationNCT06664320
Mild ANH on Pre-bypass Coagulation Function During 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 2 sites in South Korea.
Trial summary
The 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
- 2 sitesSouth Korea
- Study dates
- 28 Oct 2024to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea2 sites
Konkuk University Medical Center
Seoul, Seoul, 05030
Konkuk University Medical Center
Seoul, 143-729
Tae-Yop Kim, MD PhD, +82-2-2030-5445, taeyop@gmail.com
About this study
Official title: Impact of Mild Acute Normovolemic Hemodilution on Pre-bypass Coagulation Function During Cardiac Surgery
The 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 are randomly allocated into one of two groups: in Group-ANH, 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, the inter-group differences between maximal clot firmness of EXTEM will be determined at 10 min after ANH in Group-ANH and that at control.
Read the detailed description
Background: The 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 are randomly allocated into one of two groups: in Group-ANH(n=29), ANH is applied by using a balanced hydroxyethyl starch (HES 130/0.6); and in Group-C ANH (n=29)is not applied. Intergroup differences of INTEM, EXTEM, FIBTEM, and APTEM profiles are analyzed. after anesthesia induction (control) and after weaning from CPB and protamine neutralization (after-CPB) in both groups. In Group-ANH, those are determined after ANH (after-ANH). As a primary outcome, the inter-group difference between maximal 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, and s-Cr are determined Intergroup differences 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, hemodilution, coagulation
- Medical subject headings
- Mitral Valve Insufficiency, Mitral Valve Stenosis, Tricuspid Valve Insufficiency, Thrombosis
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
hydroxyethyl starch (HES 130/0.6)
| 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 posted29 Oct 2024
- Study start28 Oct 2024 (estimated)
- Primary completion30 Mar 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
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 (estimated)
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
- NCT06664320
- Sponsor's protocol ID
- KUH1160030-2
- Status last verified
- Oct 2024
- First submitted
- 27 Oct 2024
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Mild Acute Normovolemic Hemodilution on Pre-bypass Coagulation Function During Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06664320
- Acronym / sponsor ID
- KUH1160030-2
- Keywords
- rotational thromboelastometry, cardiac surgery, acute normovolemic hemodilution, hemodilution, coagulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Konkuk University Medical CenterUniversity, hospital or other
- Study start
- 28 Oct 2024 (estimated)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 29 Oct 2024 (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.
The 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 are randomly allocated into one of two groups: in Group-ANH, 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, the inter-group differences between maximal clot firmness of EXTEM will be determined at 10 min after ANH in Group-ANH and that at control.
Detailed description
Background: The 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 are randomly allocated into one of two groups: in Group-ANH(n=29), ANH is applied by using a balanced hydroxyethyl starch (HES 130/0.6); and in Group-C ANH (n=29)is not applied. Intergroup differences of INTEM, EXTEM, FIBTEM, and APTEM profiles are analyzed. after anesthesia induction (control) and after weaning from CPB and protamine neutralization (after-CPB) in both groups. In Group-ANH, those are determined after ANH (after-ANH). As a primary outcome, the inter-group difference between maximal 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, and s-Cr are determined Intergroup differences 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)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
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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.
Tae-Yop Kim, MD, PhD principal investigator
Konkuk University Medical Center
2 sites 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 2 sites 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: opening soon, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tae-Yop Kim, MD, PhD (+82-2-2030-5445, taeyop@gmail.com), or a site near the patient. 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 31 Oct 2024.