A Study for the therapeutic effect of NOAC in the portal vein thrombosis of liver cirrhosis patient

The therapeutic effect of dabigatran in the liver cirrhosis patients with portal vein thrombosis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0003117

Enrollment

Registered

2018-08-24

Start date

2017-10-19

Completion date

Unknown

Last updated

2023-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Treatment group: dabigatran po for six months according to eGFR. 150mg twice a day for CrCl = 50 mL/min, 110 mg twice for 30 mL/min=CrCl<50 mL/min. Control group: warfarin po, the starting dose

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: age 19-70 Liver cirrhosis patient who was diagnosed at least 6 months before the treatment Liver cirrhosis patient who has been diagnosed as thrombosis more than one out of three veins such as the left main portal vein, the right main portal vein, or the main portal trunk during recent two years. The patient who had additional SMV(superior mesenteric vein) or splenic vein thrombosis can be included.

Exclusion criteria

Exclusion criteria: 1. accompanying malignancy 2. tumor thrombi in the portal vein 3. esophageal varix F3 grade, or fundal varix above 5 cm of diameter. the patient with F1 or F2 esophageal varix who refuse to receive endoscopic esophageal variceal ligation. 4. the patient who was diagnosed as gastric ulcer bleeding (beyond Forrest’s classification ?) 5. recent history of brain or spinal cord injury 6. spontaneous history of intracranial hemorrhage 7. recent history of brain or spinal cord or opthalmologic surgery 8. AV malformation 9. arterial aneurysm in the crainal cavity 10. vascular abnormality in spinal cord or brain 11. other oral anticoagulant such as clopidogrel, LMWH, ketoconazole, cyclosporine, dronedarone 12. fertile aged woman who will be pregnant 13. liver cirrhosis with Child Pugh class C 14. ClCr < 30 mL/min

Design outcomes

Primary

Measure	Time frame
the improvement of PVT. Complete response will be the disappearance of the thrombus. Partial resolution was defined as at least 30% reduction of long diameter in thrombus,	—

Secondary

Measure	Time frame
the incidence of intracranial hemorrhage or major gastrointestinal bleeding: Forrest classification IIB lower.;the incidence of gastritis symptom.	—

Countries

Korea, Republic of

Contacts

Public ContactHee Bok Chae

Chungbuk National University Hospital

hbchae@chungbuk.ac.kr+82-43-269-6363

Outcome results