DOAC in Unusual Site Venous Thrombosis

NCT03778502 | Completed

• 1 other identifier: DUST
• Study Type: observational
• Target: 358
• Locations: 10 countries
• Sites: 24

Brief 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

Outcome Measures

Primary Outcomes (1)

• Rationale for the use of the direct oral anticoagulants

  Possible reasons for choosing one of the direct oral anticoagulant (multiple choice question)

  Baseline

Secondary Outcomes (2)

• Rate of major bleeding events

  12 months

• Rate of vascular events

  12 months

Interventions

Direct Oral Anticoagulants DRUG

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

Also known as: Apixaban, Dabigatran, Edoxaban, Rivaroxaban

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All consecutive patients who fulfill the inclusion/exclusion criteria at the participating thrombosis centers will be eligible

You may qualify if:

• Objective diagnosis of venous thrombosis not involving the upper limbs, lower limbs and pulmonary arteries
• Treatment with one of the DOAC (e.g. apixaban, dabigatran, edoxaban, rivaroxaban)

You may not qualify if:

• Enrolment in interventional studies evaluating the DOAC for the treatment of unusual site VTE

Sponsors & Collaborators

• University of Malta: lead
• Università degli Studi dell'Insubria: collaborator

Study Sites (24)

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Ottawa Hospital Research Institute

Ottawa, Canada

Location

CHU Amiens Picardie

Amiens, France

Location

Hôpital de la Cavale Blanche

Brest, France

Location

Hôpital Edouard Herriot

Lyon, France

Location

Hopital Louis Mourier

Paris, France

Location

Hôpital Européen Georges Pompidou

Paris, France

Location

Centre Hospitalier Universitaire de Saint-Etienne

Saint-Etienne, France

Location

Sheba medical center

Tel Litwinsky, Israel

Location

Azienda Ospedaliera Universitaria di Bologna

Bologna, Italy

Location

Ospedale Maggiore, Bologna

Bologna, Italy

Location

Ospedale Sant'Anna, ASST Lariana

Como, Italy

Location

Ospedale Policlinico San Martino

Genova, Italy

Location

Ospedale San Paolo

Milan, Italy

Location

University Hospital of Padova

Padua, Italy

Location

Catholic University

Rome, Italy

Location

Sapienza Università di Roma

Rome, Italy

Location

University of Insubria

Varese, Italy

Location

University of Malta

Msida, Malta

Location

Radboud University Medical Center Nijmegen

Nijmegen, Netherlands

Location

University Medical Centre Ljubljana

Ljubljana, Slovenia

Location

Clinica Universidad de Navarra

Madrid, Spain

Location

Virgen del Rocío Hospital and Instituto de Biomedicina

Seville, Spain

Location

King Chulalongkorn Memorial Hospital

Bangkok, Thailand

Location

MeSH Terms

Conditions

Intracranial Thrombosis; Retinal Vein Occlusion

Interventions

N(4)-oleylcytosine arabinoside; apixaban; Dabigatran; edoxaban; Rivaroxaban

Condition Hierarchy (Ancestors)

Intracranial Embolism and Thrombosis; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Thromboembolism; Embolism and Thrombosis; Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: December 11, 2018
• First Posted: December 19, 2018
• Study Start: October 1, 2019
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 3, 2025

Record last verified: 2025-06

Locations

MA (1); NL (1); ES (2); IL (1); SL (1); FR (6); TH (1); IT (9); US (1); CA (1)