DOAC in Unusual Site Venous Thrombosis (DUST)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Vein Thrombosis; Renal Vein Thrombosis; Retinal Vein Thrombosis; Splanchnic Vein Thrombosis; Ovarian Vein Thrombosis
• Intervention / Treatment: Drug: Direct Oral Anticoagulants

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Nicoletta Riva, MD, PhD; Phone Number: +356 2340 1870; Email: nicoletta.riva@um.edu.mt

Study Locations

• Canada
  • Ottawa, Canada
    • Not yet recruiting
    • Ottawa Hospital Research Institute
• France
  • Amiens, France
    • Recruiting
    • CHU Amiens Picardie
  • Brest, France
    • Recruiting
    • Hopital De La Cavale Blanche
  • Lyon, France
    • Recruiting
    • Hôpital Edouard Herriot
  • Paris, France
    • Not yet recruiting
    • Hôpital Européen Georges Pompidou
  • Paris, France
    • Recruiting
    • Hopital Louis Mourier
  • Saint-Étienne, France
    • Recruiting
    • Centre Hospitalier Universitaire de Saint-Etienne
• Israel
  • Tel HaShomer, Israel
    • Recruiting
    • Sheba Medical Center
• Italy
  • Bologna, Italy
    • Recruiting
    • Azienda Ospedaliera Universitaria di Bologna
  • Bologna, Italy
    • Recruiting
    • Ospedale Maggiore, Bologna
  • Como, Italy
    • Recruiting
    • Ospedale Sant'Anna, ASST Lariana
  • Genova, Italy
    • Recruiting
    • Ospedale Policlinico San Martino
  • Milan, Italy
    • Recruiting
    • Ospedale San Paolo
  • Padova, Italy
    • Recruiting
    • University Hospital of Padova
  • Rome, Italy
    • Recruiting
    • Catholic University
  • Rome, Italy
    • Recruiting
    • Sapienza Università di Roma
  • Varese, Italy
    • Recruiting
    • University of Insubria
• Malta
  • Imsida, Malta
    • Recruiting
    • University of Malta
• Netherlands
  • Nijmegen, Netherlands
    • Not yet recruiting
    • Radboud University Medical Center Nijmegen
• Slovenia
  • Ljubljana, Slovenia
    • Recruiting
    • University Medical Centre Ljubljana
• Spain
  • Madrid, Spain
    • Recruiting
    • Clinica Universidad de Navarra
  • Sevilla, Spain
    • Not yet recruiting
    • Virgen del Rocío Hospital and Instituto de Biomedicina
• Thailand
  • Bangkok, Thailand
    • Recruiting
    • King Chulalongkorn Memorial Hospital
• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Recruiting
      • Henry Ford Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rationale for the use of the direct oral anticoagulants	Possible reasons for choosing one of the direct oral anticoagulant (multiple choice question)	Baseline

Secondary Outcome Measures

Outcome Measure	Time Frame
Rate of major bleeding events	12 months
Rate of vascular events	12 months

Collaborators and Investigators

• Sponsor: University of Malta
• Collaborators: Università degli Studi dell'Insubria

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: December 11, 2018
• First Submitted That Met QC Criteria: December 14, 2018
• First Posted (Actual): December 19, 2018

Study Record Updates

• Last Update Posted (Actual): April 24, 2023
• Last Update Submitted That Met QC Criteria: April 20, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Retinal Diseases; Embolism and Thrombosis; Retinal Vein Occlusion; Thrombosis; Venous Thrombosis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Rivaroxaban; Dabigatran; Apixaban; Edoxaban; Anticoagulants
• Other Study ID Numbers: DUST

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No