Treatment of thrombosis in the abdominal veins
- Conditions
- Splanchnic vein thrombosis (SVT) is an unusual site manifestation of venous thromboembolism (VTE). It includes the Budd-Chiari syndrome (BCS), portal vein thrombosis (PVT), mesenteric vein thrombosis (MVT) and splenic vein thrombosis (spVT). PVT is the most frequent manifestation of SVT, followed by MVT.Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2014-005162-29-NL
- Lead Sponsor
- niversity of Insubria
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 100
4.1
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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
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 VKA
15.Pregnancy or lactation.
Note:
Women of childbearing potential must be willing to use an acceptable method of contraception to avoid pregnancy throughout the study. Acceptable methods of contraception include tubal ligation, oral contraceptive, barrier methods (intra-uterine device, diaphragm, femalecondom, male condom). Abstinence is an acceptable form of contraception, only insofar as patients agree to use another acceptable method of birth control, preferably a barrier method, if they become sexually active
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: In this prospective cohort study, patients presenting with acute SVT will receive rivaroxaban 15 mg bid for 3 weeks followed by rivaroxaban 20 mg once daily for a total of 3 months. The primary safety and efficacy outcomes will be measured at 3 months.;Secondary Objective: Not applicable;Primary end point(s): Primary Outcome of the study is the occurrence of major bleeding events during the 3 months of active treatment and up to 2 days after the end of study treatment.<br><br>;Timepoint(s) of evaluation of this end point: Week 3 - Month 2 - Month 6
- Secondary Outcome Measures
Name Time Method