Antithrombin III Concentrate After Liver Transplantation

Continuous Versus Intermittent Infusion of Human Antithrombin III Concentrate in the Immediate Postoperative Period After Liver Transplantation

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04219579

Enrollment

130

Registered

2020-01-07

Start date

2020-01-03

Completion date

2022-06-30

Last updated

2022-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Transplant; Complications

Keywords

antithrombin III, liver transplantation, administration method, dosage

Brief summary

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.

Interventions

DRUGAntithrombin III, continuous infusion

Antithrombin-III is administered continuously

DRUGAntithrombin III, Intermittent infusion

Antithrombin-III is administered intermittently

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Scheduled operation * Living donor liver transplantation * Adult patients (\>=18 years old)

Exclusion criteria

* Patients under 18 years old * Emergency operation * Deceased donor liver transplantation

Design outcomes

Primary

Measure	Time frame	Description
Proportion of patients within target range at postoperative 72 hours	72 hours after liver transplantation	Proportion of patients whose AT-III activity level is within the target range (80-120%)

Secondary

Measure	Time frame	Description
Proportion of AT-III level values within target range	12/24/48/72/84 hours after liver transplantation	Among the measured AT-III activity levels, proportion of the values within the target range (80-120%)
Time required for AT-III level value to fall within target range	operation day ~ postoperative day 7	Time required for AT-III level value to fall within target range (80-120%, hours)
Duration for cessation of AT-III concentrate administration	operation day ~ postoperative day 7	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%.
Proportion of patients within target range at postoperative 12/24/48/84 hours	12/24/48/84 hours after liver transplantation	Proportion of patients whose AT-III activity level is within the target range (80-120%)
Thrombosis event	operation day ~ postoperative day 7	Hepatic artery thrombosis, portal vein thrombosis
Postoperative hospital stay	through the hospital day, an average of 14 days	number of days from operation to discharge
Bleeding requiring intervention	operation day ~ postoperative day 7	Bleeding requiring intervention

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026