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Effect of Nafamostat on Postreperfusion Syndrome (PRS)

This study has been completed.
Information provided by:
Seoul National University Hospital Identifier:
First received: October 23, 2009
Last updated: May 4, 2010
Last verified: May 2010
This study intends to see the effect of nafamostat on the attenuation of postreperfusion syndrome (PRS) that frequently occurs during liver transplantation.

Condition Intervention Phase
Liver Transplantation Postreperfusion Syndrome Drug: Nafamostat Drug: Normal saline Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Effect of Nafamostat Mesilate on Hemodynamic Stability After Reperfusion of the Liver Graft

Resource links provided by NLM:

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • 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.

Enrollment: 62
Study Start Date: March 2009
Study Completion Date: April 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01001403

Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
  More Information

Responsible Party: Chul Woo Jung, Seoul National University Hospital Identifier: NCT01001403     History of Changes
Other Study ID Numbers: CWJung_futhan-liver TPL
Study First Received: October 23, 2009
Results First Received: March 21, 2010
Last Updated: May 4, 2010

Additional relevant MeSH terms:
Pathologic Processes
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Trypsin Inhibitors
Serine Proteinase Inhibitors
Complement Inactivating Agents
Immunosuppressive Agents
Immunologic Factors processed this record on June 23, 2017