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Effect of Nafamostat on Postreperfusion Syndrome (PRS)

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ClinicalTrials.gov Identifier: NCT01001403
Recruitment Status : Completed
First Posted : October 26, 2009
Results First Posted : May 3, 2010
Last Update Posted : May 11, 2010
Sponsor:
Information provided by:
Seoul National University Hospital

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

Condition or disease Intervention/treatment Phase
Liver Transplantation Postreperfusion Syndrome Drug: Nafamostat Drug: Normal saline Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Effect of Nafamostat Mesilate on Hemodynamic Stability After Reperfusion of the Liver Graft
Study Start Date : March 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : April 2010

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Arms and Interventions
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Arm Intervention/treatment
Experimental: nafamostat
The Nafamostat mesilate group received 0.2 mg/kg of nafamostat mesilate intravenously 1 min before reperfusion of the liver graft.
 Drug: Nafamostat
0.2 mg/kg as bolus 1 minute before reperfusion
Placebo Comparator: Control
The control group received 10 ml of normal saline (same volume as nafamostat)intravenously 1 min before reperfusion of the liver graft.
 Drug: Normal saline
10 ml of normal saline


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Moderate and Severe Postreperfusion Syndrome (PRS) [ Time Frame: during 5 min after reperfusion of liver graft ]
    Before entering the study, we re-defined the criteria of PRS. From our clinical experiences, two types of PRS were observed according to its severity and treatment option. "Moderate" PRS was identical to previously defined PRS: more than 30% decrease of mean arterial pressure lasting over 1 min was observed within 5 min after reperfusion of the liver graft. However, we differentiated a "severe" form of PRS, in which MAP rapidly fell below 40 mmHg, from the moderate one, because severe PRS required prompt intervention to prevent a permanent damage of vital organs.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01001403


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
More Information
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Responsible Party: Chul Woo Jung, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01001403    
Other Study ID Numbers: CWJung_futhan-liver TPL
First Posted: October 26, 2009    Key Record Dates
Results First Posted: May 3, 2010
Last Update Posted: May 11, 2010
Last Verified: May 2010
Additional relevant MeSH terms:
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Syndrome
Disease
Pathologic Processes
Nafamostat
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
 Antirheumatic Agents
Anticoagulants
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Trypsin Inhibitors
Serine Proteinase Inhibitors
Complement Inactivating Agents
Immunosuppressive Agents
Immunologic Factors