Antithrombin III Concentrate After Liver Transplantation

Liver Transplant; Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04219579
• Other study ID #: HGRyu_AT-III
• Status: Completed
• Phase: N/A
• Start date: January 3, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: June 2022
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study was designed to demonstrate more effective administration method of AT-III in immediate post-liver transplantation period.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: June 30, 2022
• Est. primary completion date: June 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Liver Transplant; Complications

Intervention

Drug:
• Antithrombin III, continuous infusion
Antithrombin-III is administered continuously
• Antithrombin III, Intermittent infusion
Antithrombin-III is administered intermittently

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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%)	72 hours after liver transplantation
Secondary	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%)	12/24/48/84 hours after liver transplantation
Secondary	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%)	12/24/48/72/84 hours after liver transplantation
Secondary	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)	operation day ~ postoperative day 7
Secondary	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%.	operation day ~ postoperative day 7
Secondary	Bleeding requiring intervention	Bleeding requiring intervention	operation day ~ postoperative day 7
Secondary	Thrombosis event	Hepatic artery thrombosis, portal vein thrombosis	operation day ~ postoperative day 7
Secondary	Postoperative hospital stay	number of days from operation to discharge	through the hospital day, an average of 14 days