An interventional study of Antithrombin III, continuous infusion and Antithrombin III, Intermittent infusion in Liver Transplant; Complications, sponsored by Seoul National University Hospital. Completed at 1 site in South Korea. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-07-01.
Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Prevention
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.
Seoul National University Hospital is the lead sponsor of 1,897 studies on the registry; 273 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Drug: Antithrombin III, continuous infusion
Every 6 hours, 500 IU of AT-III concentrate is infused through 1 hour during the first 72 hours after liver transplantation.
Drug: Antithrombin III, Intermittent infusion
Drug page: Antithrombin III
Antithrombin-III is administered continuously
Also known as: Antithrombin III, human
Antithrombin-III is administered intermittently
Also known as: Antithrombin III, human
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%)
Time frame: 72 hours after liver transplantation
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%)
Time frame: 12/24/48/84 hours after liver transplantation
Proportion of AT-III level values within target range
Among the measured AT-III activity levels, proportion of the values within the target range (80-120%)
Time frame: 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)
Time frame: 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%.
Time frame: operation day ~ postoperative day 7
Bleeding requiring intervention
Bleeding requiring intervention
Time frame: operation day ~ postoperative day 7
Thrombosis event
Hepatic artery thrombosis, portal vein thrombosis
Time frame: operation day ~ postoperative day 7
Postoperative hospital stay
number of days from operation to discharge
Time frame: through the hospital day, an average of 14 days
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Antithrombin III
Seoul National University Hospital →