Treatment of portal, mesenteric, and splenic vein thrombosis with rivaroxaban. A pilot, prospective cohort study

Phase 2

Conditions: abdominal vein thrombosis
Splanchic thrombosis
10014523

Registration Number: NL-OMON48974

Lead Sponsor: niversità degli Studi dell'Insubria

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 5

Inclusion Criteria

1. Patients aged 18 years or older
2. First episode of symptomatic, objectively diagnosed PVT, MVT, or spVT
(diagnosed by CT, MRI and/or Doppler ultrasound).
3. Signed informed consent.

Exclusion Criteria

1. Known liver cirrhosis (biopsy proven or with clinical, laboratory, or
imaging evidence of chronic liver disease, within a context of chronic
alcoholism, viral hepatitis, autoimmunity, Wilson's disease, iron overload)
2. Alanine aminotransferase level that is three times the upper limit of the
normal range or higher
3. Budd-Chiari syndrome
4. Previous or ongoing variceal bleeding
5. Presence of portal vein cavernoma at the time of diagnosis
6. Anticipated abdominal surgical procedure
7. Known bleeding diathesis
8. Platelet count <100.000 mm3
9. Creatinine clearance <30 mL/min (Cockroft-Gault formula)
10. Life expectancy of less than 3 months
11. Expected inability to take oral medications
12. Concomitant treatment with azole antimycotics and human immunodeficiency
virus protease inhibitors
13. Treatment with therapeutic doses of LMWH or UFH for more than 7 days
14. Ongoing treatment with Vitamin K Antagonists (VKA)
15. Pregnancy or lactation.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Outcome of the study is the occurrence of major bleeding events during<br /><br>the 3 months of active treatment and up to 2 days after the end of study<br /><br>treatment. </p><br>

Secondary Outcome Measures