Liver Transplantation, Postreperfusion Syndrome
Conditions
Brief summary
This study intends to see the effect of nafamostat on the attenuation of postreperfusion syndrome (PRS) that frequently occurs during liver transplantation.
Interventions
DRUGNafamostat
0.2 mg/kg as bolus 1 minute before reperfusion
DRUGNormal saline
10 ml of normal saline
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Nafamostat | 31 |
| Control | 31 |
| Total | 62 |
Baseline characteristics
| Characteristic | Control | Nafamostat | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 1 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants | 30 Participants | 58 Participants |
| Age Continuous | 52 years STANDARD_DEVIATION 11 | 51 years STANDARD_DEVIATION 10 | 52 years STANDARD_DEVIATION 11 |
| Region of Enrollment Korea, Republic of | 31 participants | 31 participants | 62 participants |
| Sex: Female, Male Female | 6 Participants | 3 Participants | 9 Participants |
| Sex: Female, Male Male | 25 Participants | 28 Participants | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 31 | 0 / 31 |
| serious Total, serious adverse events | 0 / 31 | 0 / 31 |
Outcome results
Primary
Number of Participants With Moderate and Severe Postreperfusion Syndrome (PRS)
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nafamostat | Number of Participants With Moderate and Severe Postreperfusion Syndrome (PRS) | 15 participants |
| Control | Number of Participants With Moderate and Severe Postreperfusion Syndrome (PRS) | 25 participants |