Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study was designed to demonstrate more effective administration method of AT-III in immediate post-liver transplantation period.
Antithrombin III(AT-III) concentrates have been used to prevent critical thrombosis in the immediate post-liver transplantation period without clear evidence regarding the optimal dose or administration scheme.
The investigators retrospectively analyzed the clinical data from the patients who received liver transplantation and developed pharmacokinetic model of AT-III in the previous research. According to this study, optimal AT-III activity level will be well-maintained with smaller dose with continuous infusion than with intermittent infusion which is widely accepted way of administration currently.
A prospective study was planned to show the more effective manner of AT-III concentrate administration after liver transplantation.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous infusion | Experimental | Immediately after operation, 2000 international unit (IU) of Antithrombin-III (AT-III) concentrate is loaded for 1 hour. AT-III concentrate 3000 IU is continuously infused through following 71 hours. |
|
| Intermittent infusion | Active Comparator | Every 6 hours, 500 IU of AT-III concentrate is infused through 1 hour during the first 72 hours after liver transplantation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antithrombin III, continuous infusion | Drug | Antithrombin-III is administered continuously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients within target range at postoperative 72 hours | Proportion of patients whose AT-III activity level is within the target range (80-120%) | 72 hours after liver transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients within target range at postoperative 12/24/48/84 hours | Proportion of patients whose AT-III activity level is within the target range (80-120%) | 12/24/48/84 hours after liver transplantation |
| Proportion of AT-III level values within target range |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ho Geol Ryu, MD, PhD | Seoul National University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 03080 | South Korea |
Not provided
| ID | Term |
|---|---|
| D000990 | Antithrombin III |
| ID | Term |
|---|---|
| D058833 | Antithrombin Proteins |
| D015843 | Serpins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Antithrombin III, Intermittent infusion | Drug | Antithrombin-III is administered intermittently |
|
|
Among the measured AT-III activity levels, proportion of the values within the target range (80-120%) |
| 12/24/48/72/84 hours after liver transplantation |
| Time required for AT-III level value to fall within target range | Time required for AT-III level value to fall within target range (80-120%, hours) | operation day ~ postoperative day 7 |
| Duration for cessation of AT-III concentrate administration | AT-III infusion is stopped for 24 hours when AT-III plasma activity level exceeds 120%, then restarted after the value is confirmed to be less than 120%. | operation day ~ postoperative day 7 |
| Bleeding requiring intervention | Bleeding requiring intervention | operation day ~ postoperative day 7 |
| Thrombosis event | Hepatic artery thrombosis, portal vein thrombosis | operation day ~ postoperative day 7 |
| Postoperative hospital stay | number of days from operation to discharge | through the hospital day, an average of 14 days |
| D000510 |
| Alpha-Globulins |
| D012712 | Serum Globulins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D005916 | Globulins |
| D019774 | Blood Coagulation Factor Inhibitors |
| D001685 | Biological Factors |