ClinicalTrials.gg
CompletedNCT03778502DUSTUpdated Jul 3, 2025

DOAC in Unusual Site Venous Thrombosis

An observational study in Splanchnic Vein Thrombosis, Cerebral Vein Thrombosis and Ovarian Vein Thrombosis, sponsored by University of Malta. Completed at 24 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-03.

Sponsored by University of Malta · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
358
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Splanchnic Vein Thrombosis
  • Cerebral Vein Thrombosis
  • Ovarian Vein Thrombosis
  • Renal Vein Thrombosis
  • Retinal Vein Thrombosis
03

In context

Intracranial Thrombosis

46 studies on the registry are indexed under Intracranial Thrombosis; 15 are open to participants now.

This study's enrollment of 358 is above the median of 319 across 26 observational studies indexed under Intracranial Thrombosis.

Browse Intracranial Thrombosis studies →

Lead sponsor

University of Malta is the lead sponsor of 12 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Enrolment in interventional studies evaluating the DOAC for the treatment of unusual site VTE
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
358 participants (actual)
Target follow-up
12 Months
Patient registry
Yes

Interventions

  • 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

06

What researchers measure

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)

    Time frame: Baseline

Secondary outcomes

  1. Rate of major bleeding events

    Time frame: 12 months

  2. Rate of vascular events

    Time frame: 12 months

07

Study locations

24 sites
  • Henry Ford Health System
    Detroit, Michigan 48202, United States
  • Ottawa Hospital Research Institute
    Ottawa, Canada
  • CHU Amiens Picardie
    Amiens, France
  • Hôpital de la Cavale Blanche
    Brest, France
  • Hôpital Edouard Herriot
    Lyon, France
  • Hopital Louis Mourier
    Paris, France
  • Hôpital Européen Georges Pompidou
    Paris, France
  • Centre Hospitalier Universitaire de Saint-Etienne
    Saint-Etienne, France
  • Sheba medical center
    Tel Litwinsky, Israel
  • 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, Italy
  • University of Malta
    Msida, Malta
  • Radboud University Medical Center Nijmegen
    Nijmegen, Netherlands
  • University Medical Centre Ljubljana
    Ljubljana, Slovenia
  • Clinica Universidad de Navarra
    Madrid, Spain
  • Virgen del Rocío Hospital and Instituto de Biomedicina
    Seville, Spain
  • King Chulalongkorn Memorial Hospital
    Bangkok, Thailand
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2019 to primary completion in Dec 2024, 62 months.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 11, 2018
First posted
Dec 19, 2018
StartActual
Oct 1, 2019
Primary completionActual
Dec 31, 2024
CompletionActual
Dec 31, 2024
Last update
Jul 3, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03778502
Lead sponsor
University of Malta
Collaborators
Università degli Studi dell'Insubria
Responsible party
Nicoletta Riva (Lecturer, University of Malta) — Principal investigator
First posted
Dec 19, 2018
Start date
Oct 1, 2019
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024
Last update
Jul 3, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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