## Protocol Section
### Identification Module
**NCT ID:** NCT04219579

**Brief Title:** Antithrombin III Concentrate After Liver Transplantation

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

#### Organization Study ID Info
**ID:** HGRyu_AT-III
#### Organization
**Class:** OTHER
**Full Name:** Seoul National University Hospital
### Status Module
#### Completion Date
**Date:** 2022-06-30

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-07-01

**Type:** ACTUAL

**Last Update Submit Date:** 2022-06-30

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-06-28

**Type:** ACTUAL

#### Start Date
**Date:** 2020-01-03

**Type:** ACTUAL

**Status Verified Date:** 2022-06

#### Study First Post Date
**Date:** 2020-01-07
**Type:** ACTUAL
**Study First Submit Date:** 2019-12-29
**Study First Submit QC Date:** 2020-01-05
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Seoul National University Hospital

#### Responsible Party

**Investigator Affiliation:** Seoul National University Hospital

**Investigator Full Name:** Ho Geol Ryu

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Liver Transplant; Complications

**Keywords:**

- antithrombin III

- liver transplantation

- administration method

- dosage

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 130

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Drug: Antithrombin III, continuous infusion

**Label:** Continuous infusion

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Every 6 hours, 500 IU of AT-III concentrate is infused through 1 hour during the first 72 hours after liver transplantation.

**Intervention Names:**

- Drug: Antithrombin III, Intermittent infusion

**Label:** Intermittent infusion

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Continuous infusion

**Description:** Antithrombin-III is administered continuously

**Name:** Antithrombin III, continuous infusion

**Other Names:**

- Antithrombin III, human

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Intermittent infusion

**Description:** Antithrombin-III is administered intermittently

**Name:** Antithrombin III, Intermittent infusion

**Other Names:**

- Antithrombin III, human

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Proportion of patients whose AT-III activity level is within the target range (80-120%)

**Measure:** Proportion of patients within target range at postoperative 72 hours

**Time Frame:** 72 hours after liver transplantation

#### Secondary Outcomes

**Description:** Proportion of patients whose AT-III activity level is within the target range (80-120%)

**Measure:** Proportion of patients within target range at postoperative 12/24/48/84 hours

**Time Frame:** 12/24/48/84 hours after liver transplantation

**Description:** Among the measured AT-III activity levels, proportion of the values within the target range (80-120%)

**Measure:** Proportion of AT-III level values within target range

**Time Frame:** 12/24/48/72/84 hours after liver transplantation

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

**Measure:** Time required for AT-III level value to fall within target range

**Time Frame:** operation day ~ postoperative day 7

**Description:** 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%.

**Measure:** Duration for cessation of AT-III concentrate administration

**Time Frame:** operation day ~ postoperative day 7

**Description:** Bleeding requiring intervention

**Measure:** Bleeding requiring intervention

**Time Frame:** operation day ~ postoperative day 7

**Description:** Hepatic artery thrombosis, portal vein thrombosis

**Measure:** Thrombosis event

**Time Frame:** operation day ~ postoperative day 7

**Description:** number of days from operation to discharge

**Measure:** Postoperative hospital stay

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

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Seoul

**Country:** Korea, Republic of

**Facility:** Seoul National University Hospital

**Zip:** 03080

#### Overall Officials

**Official 1:**

**Affiliation:** Seoul National University Hospital

**Name:** Ho Geol Ryu, MD, PhD

**Role:** STUDY_CHAIR

## Derived Section

### Intervention Browse Module - Ancestors

- ID: D000015842

- Term: Serine Proteinase Inhibitors

- ID: D000011480

- Term: Protease Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000000925

- Term: Anticoagulants

### Intervention Browse Module - Browse Branches

- Abbrev: Hemat

- Name: Hematinics

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: AnCoag

- Name: Anticoagulants

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: AA

- Name: Amino Acids

### Intervention Browse Module - Browse Leaves

- ID: M11110

- Name: Liver Extracts

- Relevance: LOW

- As Found: Unknown

- ID: M4307

- Name: Antithrombins

- Relevance: HIGH

- As Found: Cobalt

- ID: M4306

- Name: Antithrombin III

- Relevance: HIGH

- As Found: Injectate

- ID: M14343

- Name: Protease Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M18391

- Name: Serine Proteinase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M19609

- Name: HIV Protease Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M4244

- Name: Anticoagulants

- Relevance: LOW

- As Found: Unknown

- ID: T18

- Name: Serine

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000000991

- Term: Antithrombins

- ID: D000000990

- Term: Antithrombin III

### Misc Info Module

- Version Holder: 2024-05-24
