Effect of Nafamostat on Postreperfusion Syndrome (PRS)

NCT ID: NCT01001403

Last Updated: 2010-05-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2010-04-30

Brief Summary

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This study intends to see the effect of nafamostat on the attenuation of postreperfusion syndrome (PRS) that frequently occurs during liver transplantation.

Detailed Description

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Conditions

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Liver Transplantation Postreperfusion Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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nafamostat

The Nafamostat mesilate group received 0.2 mg/kg of nafamostat mesilate intravenously 1 min before reperfusion of the liver graft.

Group Type EXPERIMENTAL

Nafamostat

Intervention Type DRUG

0.2 mg/kg as bolus 1 minute before reperfusion

Control

The control group received 10 ml of normal saline (same volume as nafamostat)intravenously 1 min before reperfusion of the liver graft.

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

10 ml of normal saline

Interventions

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Nafamostat

0.2 mg/kg as bolus 1 minute before reperfusion

Intervention Type DRUG

Normal saline

10 ml of normal saline

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* \>= 18 year old scheduled to undergo liver transplantation

Exclusion Criteria

* Previous history of pulmonary, cardiovascular, or renal disease
* Previous history of allergic reactions to nafamostat
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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CWJung_futhan-liver TPL

Identifier Type: -

Identifier Source: org_study_id

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