Liver Transplant; ComplicationsNCT04219579
Antithrombin III Concentrate After Liver Transplantation
A study testing Antithrombin III, continuous infusion and Antithrombin III, Intermittent infusion in people with Liver Transplant; Complications, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study was designed to demonstrate more effective administration method of AT-III in immediate post-liver transplantation period. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Transplant; Complications
- What is being tested?
- Antithrombin III, continuous infusion and Antithrombin III, Intermittent infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Jan 2020to 30 Jun 2022
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled operation
- Living donor liver transplantation
- Adult patients (>=18 years old)
Who cannot join
- Patients under 18 years old
- Emergency operation
- Deceased donor liver transplantation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Continuous Versus Intermittent Infusion of Human Antithrombin III Concentrate in the Immediate Postoperative Period After Liver Transplantation
This study was designed to demonstrate more effective administration method of AT-III in immediate post-liver transplantation period.
Read the detailed description
Antithrombin III(AT-III) concentrates have been used to prevent critical thrombosis in the immediate post-liver transplantation period without clear evidence regarding the optimal dose or administration scheme.
The investigators retrospectively analyzed the clinical data from the patients who received liver transplantation and developed pharmacokinetic model of AT-III in the previous research. According to this study, optimal AT-III activity level will be well-maintained with smaller dose with continuous infusion than with intermittent infusion which is widely accepted way of administration currently.
A prospective study was planned to show the more effective manner of AT-III concentrate administration after liver transplantation.
- Conditions
- Liver Transplant; Complications
- Being tested
- Antithrombin III, continuous infusion, Antithrombin III, Intermittent infusion
- Keywords
- antithrombin III, liver transplantation, administration method, dosage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antithrombin III, continuous infusionDrug
Also called Antithrombin III, human
Antithrombin-III is administered continuously
Antithrombin III, Intermittent infusionDrug
Also called Antithrombin III, human
Antithrombin-III is administered intermittently
| Study group | Role | What they receive |
|---|---|---|
| Continuous infusion | Experimental | Immediately after operation, 2000 international unit (IU) of Antithrombin-III (AT-III) concentrate is loaded for 1 hour. AT-III concentrate 3000 IU is continuously infused through following 71 hours. Receives: Drug: Antithrombin III, continuous infusion |
| Intermittent infusion | Active comparator | Every 6 hours, 500 IU of AT-III concentrate is infused through 1 hour during the first 72 hours after liver transplantation. Receives: Drug: Antithrombin III, Intermittent infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients within target range at postoperative 72 hours
Proportion of patients whose AT-III activity level is within the target range (80-120%)
Measured: 72 hours after liver transplantation
Secondary outcomes (7)
Proportion of patients within target range at postoperative 12/24/48/84 hours
Proportion of patients whose AT-III activity level is within the target range (80-120%)
Measured: 12/24/48/84 hours after liver transplantation
Proportion of AT-III level values within target range
Among the measured AT-III activity levels, proportion of the values within the target range (80-120%)
Measured: 12/24/48/72/84 hours after liver transplantation
Time required for AT-III level value to fall within target range
Time required for AT-III level value to fall within target range (80-120%, hours)
Measured: operation day ~ postoperative day 7
Duration for cessation of AT-III concentrate administration
AT-III infusion is stopped for 24 hours when AT-III plasma activity level exceeds 120%, then restarted after the value is confirmed to be less than 120%.
Measured: operation day ~ postoperative day 7
Bleeding requiring intervention
Bleeding requiring intervention
Measured: operation day ~ postoperative day 7
Thrombosis event
Hepatic artery thrombosis, portal vein thrombosis
Measured: operation day ~ postoperative day 7
Postoperative hospital stay
number of days from operation to discharge
Measured: through the hospital day, an average of 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start3 Jan 2020
- Primary completion28 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ho Geol Ryu, Seoul National University Hospital
- Investigators
- Ho Geol Ryu, MD, PhD, Study chair, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04219579
- Sponsor's protocol ID
- HGRyu_AT-III
- Status last verified
- Jun 2022
- First submitted
- 29 Dec 2019
- Last updated
- 1 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Versus Intermittent Infusion of Human Antithrombin III Concentrate in the Immediate Postoperative Period After Liver Transplantation
- ClinicalTrials.gov ID
- NCT04219579
- Acronym / sponsor ID
- HGRyu_AT-III
- Conditions
- Liver Transplant; Complications
- Keywords
- antithrombin III, liver transplantation, administration method, dosage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 3 Jan 2020 (actual)
- Primary completion
- 28 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 7 Jan 2020 (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.
This study was designed to demonstrate more effective administration method of AT-III in immediate post-liver transplantation period.
Detailed description
Antithrombin III(AT-III) concentrates have been used to prevent critical thrombosis in the immediate post-liver transplantation period without clear evidence regarding the optimal dose or administration scheme.
The investigators retrospectively analyzed the clinical data from the patients who received liver transplantation and developed pharmacokinetic model of AT-III in the previous research. According to this study, optimal AT-III activity level will be well-maintained with smaller dose with continuous infusion than with intermittent infusion which is widely accepted way of administration currently.
A prospective study was planned to show the more effective manner of AT-III concentrate administration after liver transplantation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous infusion | Experimental | Drug: Antithrombin III, continuous infusionImmediately after operation, 2000 international unit (IU) of Antithrombin-III (AT-III) concentrate is loaded for 1 hour. AT-III concentrate 3000 IU is continuously infused through following 71 hours. |
| Intermittent infusion | Active comparator | Drug: Antithrombin III, Intermittent infusionEvery 6 hours, 500 IU of AT-III concentrate is infused through 1 hour during the first 72 hours after liver transplantation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Scheduled operation
- Living donor liver transplantation
- Adult patients (>=18 years old)
Key exclusion criteria (3 listed)
- Patients under 18 years old
- Emergency operation
- Deceased donor liver transplantation
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 |
|---|---|---|
| Antithrombin III, continuous infusionAlso: Antithrombin III, humanAntithrombin-III is administered continuously | Drug | Continuous infusion |
| Antithrombin III, Intermittent infusionAlso: Antithrombin III, humanAntithrombin-III is administered intermittently | Drug | Intermittent infusion |
Primary outcome
Proportion of patients within target range at postoperative 72 hours
Time frame: 72 hours after liver transplantation
Proportion of patients whose AT-III activity level is within the target range (80-120%)
7 secondary outcomes
Proportion of patients within target range at postoperative 12/24/48/84 hours
Time frame: 12/24/48/84 hours after liver transplantation
Proportion of AT-III level values within target range
Time frame: 12/24/48/72/84 hours after liver transplantation
Time required for AT-III level value to fall within target range
Time frame: operation day ~ postoperative day 7
Duration for cessation of AT-III concentrate administration
Time frame: operation day ~ postoperative day 7
Bleeding requiring intervention
Time frame: operation day ~ postoperative day 7
Thrombosis event
Time frame: operation day ~ postoperative day 7
Postoperative hospital stay
Time frame: through the hospital day, an average of 14 days
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 1 Jul 2022.
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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.
Ho Geol Ryu, MD, PhD study chair
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antithrombin III, continuous infusion and Antithrombin III, Intermittent infusion in people with Liver Transplant; Complications, run by Seoul National University Hospital 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 3 inclusion and 3 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 1 Jul 2022. 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?
Proportion of patients within target range at postoperative 72 hours (time frame: 72 hours after liver transplantation). 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 1 Jul 2022.