Effect of Nafamostat on Postreperfusion Syndrome (PRS)

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01001403
• Collaborator: (none)
• Enrollment: 62
• Location: 1
• Arms: 2
• Duration (Months): 13
• Patients Per Site Per Month: 4.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Liver Transplantation; Postreperfusion Syndrome	Drug: Nafamostat; Drug: Normal saline	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 62 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Prevention
• Official Title: Effect of Nafamostat Mesilate on Hemodynamic Stability After Reperfusion of the Liver Graft
• Study Start Date: Mar 1, 2009
• Actual Primary Completion Date: Mar 1, 2010
• Actual Study Completion Date: Apr 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: nafamostat The Nafamostat mesilate group received 0.2 mg/kg of nafamostat mesilate intravenously 1 min before reperfusion of the liver graft.	Drug: Nafamostat; 0.2 mg/kg as bolus 1 minute before reperfusion
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.	Drug: Normal saline; 10 ml of normal saline

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Moderate and Severe Postreperfusion Syndrome (PRS) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of	110-744

Sponsors and Collaborators

• Seoul National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01001403
• Other Study ID Numbers: CWJung_futhan-liver TPL
• First Posted: Oct 26, 2009
• Last Update Posted: May 11, 2010
• Last Verified: May 1, 2010

• Additional relevant MeSH terms: Syndrome; Nafamostat

Study Results

Participant Flow

Arm/Group Title	Nafamostat	Control
Arm/Group Description
Period Title: Overall Study
STARTED	31	31
COMPLETED	31	31
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Nafamostat	Control	Total
Arm/Group Description	Total of all reporting groups
Overall Participants	31	31	62
Age (Count of Participants)
<=18 years	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 (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	51 (10)	52 (11)	52 (11)
Sex: Female, Male (Count of Participants)
Female	3 9.7%	6 19.4%	9 14.5%
Male	28 90.3%	25 80.6%	53 85.5%
Region of Enrollment (participants) [Number]
Korea, Republic of	31 100%	31 100%	62 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Moderate and Severe Postreperfusion Syndrome (PRS)
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Nafamostat	Control
Arm/Group Description
Measure Participants	31	31
Number [participants]	15 48.4%	25 80.6%

Adverse Events

Arm/Group Title	Nafamostat		Control
Arm/Group Description
All Cause Mortality
	Nafamostat		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Nafamostat		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/31 (0%)		0/31 (0%)
Other (Not Including Serious) Adverse Events
	Nafamostat		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/31 (0%)		0/31 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.