Clinical trial NCT03778502: DOAC in Unusual Site Venous Thrombosis
Official title: International Registry on the Use of the Direct Oral Anticoagulants for the Treatment of Unusual Site Venous Thromboembolism
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Splanchnic Vein Thrombosis
Cerebral Vein Thrombosis
Ovarian Vein Thrombosis
Renal Vein Thrombosis
Retinal Vein Thrombosis
Lead sponsor: University of Malta
Sponsor class: OTHER
Collaborators: name: Università degli Studi dell'Insubria
First posted: 2018-12-19
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive patients who fulfill the inclusion/exclusion criteria at the participating thrombosis centers will be eligible

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.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

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

Primary outcomes:
measure: Rationale for the use of the direct oral anticoagulants
timeFrame: Baseline
Secondary outcomes:
measure: Rate of major bleeding events
timeFrame: 12 months
measure: Rate of vascular events
timeFrame: 12 months
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute
city: Amiens
country: France
facility: CHU Amiens Picardie
city: Brest
country: France
facility: Hôpital de la Cavale Blanche
city: Lyon
country: France
facility: Hôpital Edouard Herriot
city: Paris
country: France
facility: Hopital Louis Mourier
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Saint-Étienne
country: France
facility: Centre Hospitalier Universitaire de Saint-Etienne
city: Tel HaShomer
country: Israel
facility: Sheba medical center
city: Bologna
country: Italy
facility: Azienda Ospedaliera Universitaria di Bologna
city: Bologna
country: Italy
facility: Ospedale Maggiore, Bologna
city: Como
country: Italy
facility: Ospedale Sant'Anna, ASST Lariana
city: Genova
country: Italy
facility: Ospedale Policlinico San Martino
city: Milan
country: Italy
facility: Ospedale San Paolo
city: Padova
country: Italy
facility: University Hospital of Padova
city: Rome
country: Italy
facility: Catholic University
city: Rome
country: Italy
facility: Sapienza Università di Roma
city: Varese
country: Italy
facility: University of Insubria
city: Imsida
country: Malta
facility: University of Malta
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center Nijmegen
city: Ljubljana
country: Slovenia
facility: University Medical Centre Ljubljana
city: Madrid
country: Spain
facility: Clinica Universidad de Navarra
city: Sevilla
country: Spain
facility: Virgen del Rocío Hospital and Instituto de Biomedicina
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital
Study officials:
References: