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Effect of Nafamostat on Postreperfusion Syndrome (PRS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE October 23, 2009
First Posted Date  ICMJE October 26, 2009
Results First Submitted Date  ICMJE March 21, 2010
Results First Posted Date  ICMJE May 3, 2010
Last Update Posted Date May 11, 2010
Study Start Date  ICMJE March 2009
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 4, 2010)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 23, 2009)
mean blood pressure immediately after reperfusion [ Time Frame: during liver transplantation ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Nafamostat on Postreperfusion Syndrome (PRS)
Official Title  ICMJE Effect of Nafamostat Mesilate on Hemodynamic Stability After Reperfusion of the Liver Graft
Brief Summary This study intends to see the effect of nafamostat on the attenuation of postreperfusion syndrome (PRS) that frequently occurs during liver transplantation.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Liver Transplantation
  • Postreperfusion Syndrome
Intervention  ICMJE
  • Drug: Nafamostat
    0.2 mg/kg as bolus 1 minute before reperfusion
  • Drug: Normal saline
    10 ml of normal saline
Study Arms  ICMJE
  • Experimental: nafamostat
    The Nafamostat mesilate group received 0.2 mg/kg of nafamostat mesilate intravenously 1 min before reperfusion of the liver graft.
    Intervention: Drug: Nafamostat
  • 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.
    Intervention: Drug: Normal saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 8, 2010)
62
Original Estimated Enrollment  ICMJE
 (submitted: October 23, 2009)
64
Actual Study Completion Date  ICMJE April 2010
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01001403
Other Study ID Numbers  ICMJE CWJung_futhan-liver TPL
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chul Woo Jung, Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Seoul National University Hospital
Verification Date May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP