Treatment of Splanchnic Vein Thrombosis With Rivaroxaban. A Pilot, Prospective Cohort Study

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Anticoagulant therapy is generally recommended for all patients presenting with acute symptomatic splanchnic vein thrombosis, starting with either low-molecular weight heparin (LMWH) or unfractionated heparin and continuing with the vitamin K antagonists in most patients. Rivaroxaban is approved for the treatment of deep vein thrombosis and pulmonary embolism, but no studies have assessed the safety of rivaroxaban in the setting of splanchnic vein thrombosis. The investigators aim to collect prospective information on the safety of rivaroxaban in a pilot cohort of 100 patients with acute splanchnic vein thrombosis without liver cirrhosis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Università degli Studi dell'Insubria
• Collaborator: Ottawa Hospital Research Institute
• Treatments: Rivaroxaban

Criteria

Inclusion criteria:

• Consecutive patients aged 18 years or older

• first episode of symptomatic, objectively diagnosed PVT, MVT, or spVT

• signed informed consent.

Exclusion criteria:

• 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)

• alanine aminotransferase level that is three times the upper limit of the normal range or higher

• Budd-Chiari syndrome

• previous or ongoing vatical bleeding

• presence of portal vein cavernoma at the time of diagnosis

• anticipated abdominal surgical procedure

• known bleeding diathesis

• platelet count <100.000 mm3

• creatinine clearance <30 mL/min (Cockroft-Gault formula)

• life expectancy of less than 3 months

• expected inability to take oral medications

• concomitant treatment with azole antimycotics and human immunodeficiency virus protease inhibitors - treatment with therapeutic doses of LMWH or UFH for more than 7 days

• ongoing treatment with VKA

• pregnancy or lactation