Effect of Nafamostat on Postreperfusion Syndrome (PRS)

Liver Transplantation Clinical Trial

Official title:

Effect of Nafamostat Mesilate on Hemodynamic Stability After Reperfusion of the Liver Graft

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01001403
• Other study ID #: CWJung_futhan-liver TPL
• Status: Completed
• Phase: Phase 4
• First received: October 23, 2009
• Last updated: May 4, 2010
• Start date: March 2009
• Est. completion date: April 2010

Study information

• Verified date: May 2010
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: April 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Liver Transplantation
• Postreperfusion Syndrome

Intervention

Drug:
• Nafamostat
0.2 mg/kg as bolus 1 minute before reperfusion
• Normal saline
10 ml of normal saline

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Moderate and Severe Postreperfusion Syndrome (PRS)	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.	during 5 min after reperfusion of liver graft	No