Splanchnic Vein ThrombosisDUSTNCT03778502
DOAC in Unusual Site Venous Thrombosis
An observational study of Splanchnic Vein Thrombosis and Cerebral Vein Thrombosis, run by University of Malta at 24 sites in 10 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Splanchnic Vein Thrombosis, Cerebral Vein Thrombosis, Ovarian Vein Thrombosis
- What is being tested?
- Direct Oral Anticoagulants
- Type of treatment
- Pill or oral medicine
- How many people
- 358 participants
- Where
- 24 sitesin 10 countries
- Study dates
- 1 Oct 2019to 31 Dec 2024
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive patients who fulfill the inclusion/exclusion criteria at the participating thrombosis centers will be eligible
Who may be able to join
- 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)
Who cannot join
- Enrolment in interventional studies evaluating the DOAC for the treatment of unusual site VTE
Trial locations and contacts
24 sites in 10 countries.
24 sites in 10 countries
Italy9 sites
Azienda Ospedaliera Universitaria di Bologna
Bologna
Ospedale Maggiore, Bologna
Bologna
Ospedale Sant'Anna, ASST Lariana
Como
Ospedale Policlinico San Martino
Genova
Ospedale San Paolo
Milan
University Hospital of Padova
Padova
Catholic University
Rome
Sapienza Università di Roma
Rome
University of Insubria
Varese
France6 sites
CHU Amiens Picardie
Amiens
Hôpital de la Cavale Blanche
Brest
Hôpital Edouard Herriot
Lyon
Hopital Louis Mourier
Paris
Hôpital Européen Georges Pompidou
Paris
Centre Hospitalier Universitaire de Saint-Etienne
Saint-Etienne
Spain2 sites
Clinica Universidad de Navarra
Madrid
Virgen del Rocío Hospital and Instituto de Biomedicina
Seville
About this study
Official title: 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.
- Conditions
- Splanchnic Vein Thrombosis, Cerebral Vein Thrombosis, Ovarian Vein Thrombosis, Renal Vein Thrombosis, Retinal Vein Thrombosis
- Being tested
- Direct Oral Anticoagulants
- Medical subject headings
- Intracranial Thrombosis, Retinal Vein Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct Oral AnticoagulantsDrug
Also called Apixaban, Dabigatran, Edoxaban, Rivaroxaban
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Rationale for the use of the direct oral anticoagulants
Possible reasons for choosing one of the direct oral anticoagulant (multiple choice question)
Measured: Baseline
Secondary outcomes (2)
Rate of major bleeding events
Measured: 12 months
Rate of vascular events
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start1 Oct 2019
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Splanchnic Vein ThrombosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 358 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University of Malta
- Sponsor type
- University, hospital or other
- Collaborators
- Università degli Studi dell'Insubria
- Responsible party
- Principal investigator, Nicoletta Riva, University of Malta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03778502
- Sponsor's protocol ID
- DUST
- Acronym
- DUST
- Status last verified
- Jun 2025
- First submitted
- 11 Dec 2018
- Last updated
- 3 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Registry on the Use of the Direct Oral Anticoagulants for the Treatment of Unusual Site Venous Thromboembolism
- ClinicalTrials.gov ID
- NCT03778502
- Acronym / sponsor ID
- DUST / DUST
- Conditions
- Splanchnic Vein Thrombosis, Cerebral Vein Thrombosis, Ovarian Vein Thrombosis, Renal Vein Thrombosis, Retinal Vein Thrombosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 358 participants (actual)
- Lead sponsor
- University of MaltaUniversity, hospital or other
- Collaborators
- Università degli Studi dell'Insubria
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 19 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients who fulfill the inclusion/exclusion criteria at the participating thrombosis centers will be eligible
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (1 listed)
- Enrolment in interventional studies evaluating the DOAC for the treatment of unusual site VTE
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Direct Oral AnticoagulantsAlso: Apixaban, Dabigatran, Edoxaban, RivaroxabanConsecutive 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 | Drug | – |
Primary outcome
Rationale for the use of the direct oral anticoagulants
Time frame: Baseline
Possible reasons for choosing one of the direct oral anticoagulant (multiple choice question)
2 secondary outcomes
Rate of major bleeding events
Time frame: 12 months
Rate of vascular events
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
24 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Splanchnic Vein Thrombosis and Cerebral Vein Thrombosis, run by University of Malta at 24 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Italy, France, Spain, United States, Canada and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rationale for the use of the direct oral anticoagulants (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.