DOAC in Unusual Site Venous Thrombosis

Cerebral Vein Thrombosis Clinical Trial

— DUST  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03778502
• Other study ID #: DUST
• Status: Recruiting
• Start date: October 1, 2019
• Est. completion date: December 2024

Study information

• Verified date: April 2023
• Source: University of Malta
• Contact: Nicoletta Riva, MD, PhD
• Phone: +356 2340 1870
• Email: nicoletta.riva[@]um.edu.mt
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Canada	Ottawa Hospital Research Institute	Ottawa
France	CHU Amiens Picardie	Amiens
France	Hôpital de la Cavale Blanche	Brest
France	Hôpital Edouard Herriot	Lyon
France	Hôpital Européen Georges Pompidou	Paris
France	Hopital Louis Mourier	Paris
France	Centre Hospitalier Universitaire de Saint-Etienne	Saint-Étienne
Israel	Sheba medical center	Tel HaShomer
Italy	Azienda Ospedaliera Universitaria di Bologna	Bologna
Italy	Ospedale Maggiore, Bologna	Bologna
Italy	Ospedale Sant'Anna, ASST Lariana	Como
Italy	Ospedale Policlinico San Martino	Genova
Italy	Ospedale San Paolo	Milan
Italy	University Hospital of Padova	Padova
Italy	Catholic University	Rome
Italy	Sapienza Università di Roma	Rome
Italy	University of Insubria	Varese
Malta	University of Malta	Imsida
Netherlands	Radboud University Medical Center Nijmegen	Nijmegen
Slovenia	University Medical Centre Ljubljana	Ljubljana
Spain	Clinica Universidad de Navarra	Madrid
Spain	Virgen del Rocío Hospital and Instituto de Biomedicina	Sevilla
Thailand	King Chulalongkorn Memorial Hospital	Bangkok
United States	Henry Ford Health System	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Malta	Università degli Studi dell'Insubria

Countries where clinical trial is conducted

United States,  Canada,  France,  Israel,  Italy,  Malta,  Netherlands,  Slovenia,  Spain,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rationale for the use of the direct oral anticoagulants	Possible reasons for choosing one of the direct oral anticoagulant (multiple choice question)	Baseline
Secondary	Rate of major bleeding events		12 months
Secondary	Rate of vascular events		12 months