Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-29 @ 11:48 PM
Study NCT ID:
NCT07461532
Status:
RECRUITING
Last Update Posted:
2026-03-25
First Post:
2026-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Apixaban in Treating Portal Vein Thrombosis Occurring More Than One Year After LSD
Sponsor:
Northern Jiangsu People's Hospital
Organization:
Study Overview
Official Title:
Efficacy of Apixaban in Treating Portal Vein Thrombosis Occurring More Than One Year After Laparoscopic Splenectomy and Azygoportal Disconnection
Status:
RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether Apixaban is effective and safe in the treatment of portal vein thrombosis at one year and long-term follow-up in liver cirrhotic patients after laparoscopic splenectomy and azygoportal disconnection.
Detailed Description:
After successful screening, liver cirrhotic patients of any etiology without portal vein thrombosis will be enrolled. From postoperative day 1, patients in the apixaban group will receive oral apixaban 2.5 mg twice daily for six months as monotherapy. Doppler ultrasound screening for portal vein thrombosis (PVT) or spleno-mesenteric thrombosis will be performed for all patients at baseline, on postoperative day 7 (POD 7), and at postoperative months 1, 3, 6, 12, 18, 24, and 36 (POM 1, 3, 6, 12, 18, 24, 36). All patients will complete the six-month prophylactic therapy regardless of Doppler findings regarding PVT occurrence. After the six-month treatment period, patients will be evaluated and will discontinue therapy to enter the monitoring phase. Long-term follow-up will continue up to 36 months to evaluate the primary outcome of PVT treatment effect and secondary outcomes including portal hypertension progression, rebleeding rates, hepatic encephalopathy, and survival.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: