Effect of Nafamostat on Postreperfusion Syndrome (PRS)
Effect of Nafamostat Mesilate on Hemodynamic Stability After Reperfusion of the Liver Graft
1 other identifier
interventional
62
1 country
1
Brief Summary
This study intends to see the effect of nafamostat on the attenuation of postreperfusion syndrome (PRS) that frequently occurs during liver transplantation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Mar 2009
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 23, 2009
CompletedFirst Posted
Study publicly available on registry
October 26, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedResults Posted
Study results publicly available
May 3, 2010
CompletedMay 11, 2010
May 1, 2010
1 year
October 23, 2009
March 21, 2010
May 4, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
nafamostat
EXPERIMENTALThe Nafamostat mesilate group received 0.2 mg/kg of nafamostat mesilate intravenously 1 min before reperfusion of the liver graft.
Control
PLACEBO COMPARATORThe control group received 10 ml of normal saline (same volume as nafamostat)intravenously 1 min before reperfusion of the liver graft.
Interventions
Eligibility Criteria
You may qualify if:
- \>= 18 year old scheduled to undergo liver transplantation
You may not qualify if:
- Previous history of pulmonary, cardiovascular, or renal disease
- Previous history of allergic reactions to nafamostat
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, Seoul, 110-744, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- CW Jung
- Organization
- Seoul National University Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 23, 2009
First Posted
October 26, 2009
Study Start
March 1, 2009
Primary Completion
March 1, 2010
Study Completion
April 1, 2010
Last Updated
May 11, 2010
Results First Posted
May 3, 2010
Record last verified: 2010-05