NCT03778502

DOAC in Unusual Site Venous Thrombosis

International Registry on the Use of the Direct Oral Anticoagulants for the Treatment of Unusual Site Venous Thromboembolism

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 358 (actual)
• Sponsor: University of Malta · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Unusual site venous thromboembolism (VTE) refers to thrombosis occurring in venous districts outside the veins of the lower extremities and the pulmonary arteries, and includes splanchnic vein thrombosis (SVT), cerebral vein thrombosis (CVT), retinal vein thrombosis, ovarian vein thrombosis, and renal vein thrombosis. The use of the novel direct oral anticoagulants (DOAC), thrombin or factor Xa-inhibitors (such as dabigatran, apixaban, edoxaban, rivaroxaban), in patients with unusual VTE in clinical practice is increasing. Through an international multicentre prospective registry, the investigators aim to evaluate the rationale for the use of the DOAC for the treatment of unusual site VTE and to assess the safety and effectiveness of this approach in real life clinical practice.

Conditions

• Splanchnic Vein Thrombosis
• Cerebral Vein Thrombosis
• Ovarian Vein Thrombosis
• Renal Vein Thrombosis
• Retinal Vein Thrombosis

Interventions

Type	Name	Description
DRUG	Direct Oral Anticoagulants	Consecutive adult patients with objectively diagnosed unusual site venous thrombosis and treated with one of the DOAC (e.g. apixaban, dabigatran, edoxaban, rivaroxaban) will be eligible for this observational prospective registry

Timeline

• Start date: 2019-10-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2018-12-19
• Last updated: 2025-07-03

Locations

24 sites across 10 countries: United States, Canada, France, Israel, Italy, Malta, Netherlands, Slovenia, Spain, Thailand