NCT04219579

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 29, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

January 3, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 7, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2022

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

July 1, 2022

Status Verified

June 1, 2022

Enrollment Period

2.5 years

First QC Date

December 29, 2019

Last Update Submit

June 30, 2022

Conditions

Liver Transplant; Complications

Keywords

antithrombin IIIliver transplantationadministration methoddosage

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Proportion of patients within target range at postoperative 12/24/48/84 hours

    12/24/48/84 hours after liver transplantation

  • Proportion of AT-III level values within target range

    12/24/48/72/84 hours after liver transplantation

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

    operation day ~ postoperative day 7

  • Duration for cessation of AT-III concentrate administration

    operation day ~ postoperative day 7

  • Bleeding requiring intervention

    operation day ~ postoperative day 7

  • +2 more secondary outcomes

Study Arms (2)

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.

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.

Drug: Antithrombin III, Intermittent infusion

Interventions

Antithrombin III, continuous infusionDRUG

Antithrombin-III is administered continuously

Also known as: Antithrombin III, human
Continuous infusion
Antithrombin III, Intermittent infusionDRUG

Antithrombin-III is administered intermittently

Also known as: Antithrombin III, human
Intermittent infusion

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Interventions

Antithrombin III

Intervention Hierarchy (Ancestors)

Antithrombin ProteinsSerpinsPeptidesAmino Acids, Peptides, and ProteinsAlpha-GlobulinsSerum GlobulinsBlood ProteinsProteinsGlobulinsBlood Coagulation Factor InhibitorsBiological Factors

Study Officials

  • Ho Geol Ryu, MD, PhD

    Seoul National University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 29, 2019

First Posted

January 7, 2020

Study Start

January 3, 2020

Primary Completion

June 28, 2022

Study Completion

June 30, 2022

Last Updated

July 1, 2022

Record last verified: 2022-06

Locations

KR(1)