DOAC in Unusual Site Venous Thrombosis

Recruiting

• Conditions: Retinal Vein Thrombosis; Splanchnic Vein Thrombosis; Cerebral Vein Thrombosis; Ovarian Vein Thrombosis; Renal Vein Thrombosis

• Registration Number: NCT03778502
• Lead Sponsor: University of Malta

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-11
• Study First Submitted QC: 2018-12-14
• Study First Posted: 2018-12-19
• Study Start: 2019-10-01
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-20
• Last Update Posted: 2023-04-24
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rationale for the use of the direct oral anticoagulants	Baseline	Possible reasons for choosing one of the direct oral anticoagulant (multiple choice question)

Secondary Outcome Measures

Name	Time	Method
Rate of vascular events	12 months
Rate of major bleeding events	12 months

Trial Locations

Locations (24)

CHU Amiens Picardie; 🇫🇷 Amiens, France

Catholic University; 🇮🇹 Rome, Italy

Ottawa Hospital Research Institute; 🇨🇦 Ottawa, Canada

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-Étienne, France

University of Malta; 🇲🇹 Imsida, 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; 🇪🇸 Sevilla, Spain

King Chulalongkorn Memorial Hospital; 🇹🇭 Bangkok, Thailand

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States

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

Sapienza Università di Roma; 🇮🇹 Rome, Italy

University of Insubria; 🇮🇹 Varese, Italy

Sheba medical center; 🇮🇱 Tel HaShomer, Israel