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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 Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Prevention
Conditions Liver Transplantation
Postreperfusion Syndrome
Interventions Drug: Nafamostat
Drug: Normal saline
Enrollment 62
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Nafamostat Control
Hide Arm/Group Description [Not Specified] [Not Specified]
Period Title: Overall Study
Started 31 31
Completed 31 31
Not Completed 0 0
Arm/Group Title Nafamostat Control Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 31 31 62
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 31 participants 62 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
30
  96.8%
28
  90.3%
58
  93.5%
>=65 years
1
   3.2%
3
   9.7%
4
   6.5%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 31 participants 31 participants 62 participants
51  (10) 52  (11) 52  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 31 participants 62 participants
Female
3
   9.7%
6
  19.4%
9
  14.5%
Male
28
  90.3%
25
  80.6%
53
  85.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 31 participants 31 participants 62 participants
31 31 62
1.Primary Outcome
Title Number of Participants With Moderate and Severe Postreperfusion Syndrome (PRS)
Hide Description 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.
Time Frame during 5 min after reperfusion of liver graft
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nafamostat Control
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 31 31
Measure Type: Number
Unit of Measure: participants
15 25
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Nafamostat Control
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Nafamostat Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Nafamostat Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/31 (0.00%)   0/31 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Nafamostat Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/31 (0.00%)   0/31 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: CW Jung
Organization: Seoul National University Hospital
Phone: 82-2-2072-2467 ext 9
EMail: spss@snuh.org
Layout table for additonal information
Responsible Party: Chul Woo Jung, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01001403    
Other Study ID Numbers: CWJung_futhan-liver TPL
First Submitted: October 23, 2009
First Posted: October 26, 2009
Results First Submitted: March 21, 2010
Results First Posted: May 3, 2010
Last Update Posted: May 11, 2010