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Trial Outcomes & Findings for Effect of Nafamostat on Postreperfusion Syndrome (PRS) (NCT NCT01001403)

NCT ID: NCT01001403

Last Updated: 2010-05-11

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

62 participants

Primary outcome timeframe

during 5 min after reperfusion of liver graft

Results posted on

2010-05-11

Participant Flow

Participant milestones

Participant milestones
Measure
Nafamostat
Control
Overall Study
STARTED
31
31
Overall Study
COMPLETED
31
31
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Nafamostat on Postreperfusion Syndrome (PRS)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Nafamostat
n=31 Participants
Control
n=31 Participants
Total
n=62 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
30 Participants
n=5 Participants
28 Participants
n=7 Participants
58 Participants
n=5 Participants
Age, Categorical
>=65 years
1 Participants
n=5 Participants
3 Participants
n=7 Participants
4 Participants
n=5 Participants
Age Continuous
51 years
STANDARD_DEVIATION 10 • n=5 Participants
52 years
STANDARD_DEVIATION 11 • n=7 Participants
52 years
STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male
Female
3 Participants
n=5 Participants
6 Participants
n=7 Participants
9 Participants
n=5 Participants
Sex: Female, Male
Male
28 Participants
n=5 Participants
25 Participants
n=7 Participants
53 Participants
n=5 Participants
Region of Enrollment
Korea, Republic of
31 participants
n=5 Participants
31 participants
n=7 Participants
62 participants
n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Nafamostat
n=31 Participants
Control
n=31 Participants
Number of Participants With Moderate and Severe Postreperfusion Syndrome (PRS)
15 participants
25 participants

Adverse Events

Nafamostat

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

CW Jung

Seoul National University Hospital

Phone: 82-2-2072-2467

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place