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DOAC in Unusual Site Venous Thrombosis

NCT ID: NCT03778502

Last Updated: 2025-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

358 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-01

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Splanchnic Vein Thrombosis Cerebral Vein Thrombosis Ovarian Vein Thrombosis Renal Vein Thrombosis Retinal Vein Thrombosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Apixaban Dabigatran Edoxaban Rivaroxaban

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Università degli Studi dell'Insubria

OTHER

Sponsor Role collaborator

University of Malta

OTHER

Sponsor Role lead

Responsible Party

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Nicoletta Riva

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Henry Ford Health System

Detroit, Michigan, United States

Site Status

Ottawa Hospital Research Institute

Ottawa, , Canada

Site Status

CHU Amiens Picardie

Amiens, , France

Site Status

Hôpital de la Cavale Blanche

Brest, , France

Site Status

Hôpital Edouard Herriot

Lyon, , France

Site Status

Hopital Louis Mourier

Paris, , France

Site Status

Hôpital Européen Georges Pompidou

Paris, , France

Site Status

Centre Hospitalier Universitaire de Saint-Etienne

Saint-Etienne, , France

Site Status

Sheba medical center

Tel Litwinsky, , Israel

Site Status

Azienda Ospedaliera Universitaria di Bologna

Bologna, , Italy

Site Status

Ospedale Maggiore, Bologna

Bologna, , Italy

Site Status

Ospedale Sant'Anna, ASST Lariana

Como, , Italy

Site Status

Ospedale Policlinico San Martino

Genova, , Italy

Site Status

Ospedale San Paolo

Milan, , Italy

Site Status

University Hospital of Padova

Padua, , Italy

Site Status

Catholic University

Rome, , Italy

Site Status

Sapienza Università di Roma

Rome, , Italy

Site Status

University of Insubria

Varese, , Italy

Site Status

University of Malta

Msida, , Malta

Site Status

Radboud University Medical Center Nijmegen

Nijmegen, , Netherlands

Site Status

University Medical Centre Ljubljana

Ljubljana, , Slovenia

Site Status

Clinica Universidad de Navarra

Madrid, , Spain

Site Status

Virgen del Rocío Hospital and Instituto de Biomedicina

Seville, , Spain

Site Status

King Chulalongkorn Memorial Hospital

Bangkok, , Thailand

Site Status

Countries

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United States Canada France Israel Italy Malta Netherlands Slovenia Spain Thailand

Other Identifiers

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DUST

Identifier Type: -

Identifier Source: org_study_id

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