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Completed

NCT Number: NCT04219579

Antithrombin III Concentrate After Liver Transplantation

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

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Key information

Conditions

Liver Transplant; Complications

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Antithrombin III, continuous infusion

Drug

Antithrombin-III is administered continuously

Other names: Antithrombin III, human

Antithrombin III, Intermittent infusion

Drug

Antithrombin-III is administered intermittently

Other names: Antithrombin III, human

Primary outcomes

  1. 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%)

Secondary outcomes

  1. 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 patients whose AT-III activity level is within the target range (80-120%)

  2. Proportion of AT-III level values within target range

    Time frame: 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%)

  3. Time required for AT-III level value to fall within target range

    Time frame: operation day ~ postoperative day 7

    Time required for AT-III level value to fall within target range (80-120%, hours)

  4. Duration for cessation of AT-III concentrate administration

    Time frame: 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%.

  5. Bleeding requiring intervention

    Time frame: operation day ~ postoperative day 7

    Bleeding requiring intervention

  6. Thrombosis event

    Time frame: operation day ~ postoperative day 7

    Hepatic artery thrombosis, portal vein thrombosis

  7. Postoperative hospital stay

    Time frame: through the hospital day, an average of 14 days

    number of days from operation to discharge

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 7, 2020
Registry last updated
Jul 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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