Text Size

Effect of Nafamostat on Postreperfusion Syndrome (PRS)

This study has been completed.
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01001403
First received: October 23, 2009
Last updated: May 4, 2010
Last verified: May 2010
History of Changes
Results First Received: March 21, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Prevention
Conditions: Liver Transplantation
Postreperfusion Syndrome
Interventions: Drug: Nafamostat
Drug: Normal saline

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Nafamostat No text entered.
Control No text entered.

Participant Flow:   Overall Study
    Nafamostat     Control  
STARTED     31     31  
COMPLETED     31     31  
NOT COMPLETED     0     0  



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
Nafamostat No text entered.
Control No text entered.
Total Total of all reporting groups

Baseline Measures
    Nafamostat     Control     Total  
Number of Participants  
[units: participants]
 		  31     31     62  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     30     28     58  
>=65 years     1     3     4  
Age  
[units: years]
Mean ± Standard Deviation 		  51  ± 10     52  ± 11     52  ± 11  
Gender  
[units: participants]
 		     
Female     3     6     9  
Male     28     25     53  
Region of Enrollment  
[units: participants]
 		     
Korea, Republic of     31     31     62  



  Outcome Measures

1.  Primary:   Number of Participants With Moderate and Severe Postreperfusion Syndrome (PRS)   [ Time Frame: during 5 min after reperfusion of liver graft ]
  Show Outcome Measure 1


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: CW Jung
Organization: Seoul National University Hospital
phone: 82-2-2072-2467 ext 9
e-mail: spss@snuh.org


No publications provided


Responsible Party: Chul Woo Jung, Seoul National University Hospital
ClinicalTrials.gov 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
Health Authority: Korea: Institutional Review Board