Antithrombin III Concentrate After Liver Transplantation

Not Applicable

Completed

• Conditions: Liver Transplant; Complications
• Interventions: Drug: Antithrombin III, Intermittent infusion; Drug: Antithrombin III, continuous infusion

• Registration Number: NCT04219579
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study First Submitted: 2019-12-29
• Study Start: 2020-01-03
• Study First Submitted QC: 2020-01-05
• Study First Posted: 2020-01-07
• Status Verified: 2022-06
• Primary Completion: 2022-06-28
• Study Completion: 2022-06-30
• Last Update Submitted: 2022-06-30
• Last Update Posted: 2022-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intermittent infusion	Antithrombin III, Intermittent infusion	Every 6 hours, 500 IU of AT-III concentrate is infused through 1 hour during the first 72 hours after liver transplantation.
Continuous infusion	Antithrombin III, continuous infusion	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Bleeding requiring intervention	operation day ~ postoperative day 7	Bleeding requiring intervention
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)
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%)
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%)
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%.
Postoperative hospital stay	through the hospital day, an average of 14 days	number of days from operation to discharge
Thrombosis event	operation day ~ postoperative day 7	Hepatic artery thrombosis, portal vein thrombosis

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of