Mesenteric Venous Thrombosis Clinical Trials

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Randomized Controlled Multicenter Study Comparing Steroid Therapy Plus Anticoagulants to Steroid Therapy Alone in Deep Venous Thrombosis of Behçet's Syndrome

Status: Recruiting
Location: See all (17) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

In patients with Behçet's syndrome (BS), deep venous thrombosis (DVT) is thought to result from inflammation of the vessel wall rather than hyper coagulability. Post Thrombotic Syndrome (PTS) is frequent especially with recurrent episodes of deep vein thrombosis and may result in leg ulcers that are very difficult to treat. Vascular involvement is a major cause of morbidity and mortality among BS patients. However, one of the most controversial issues regarding the management of BS is whether DVT should be treated with anticoagulants. Moreover, use of anticoagulants exposes patients to serious bleeding, especially in those who presents simultaneous arterial aneurysms. However, many physicians are still using anticoagulants. This is the first prospective, randomized study assessing benefits of corticosteroids associated with anticoagulant compared to that of corticosteroids alone in DVT in BS patients. It will validate or not the use of anticoagulants in those situations. It will allow a direct comparison of the safety profile of those two schemes of treatment.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18 years old

• Diagnosis of BS according to the international criteria

• First or recurrent deep venous thrombosis diagnosed on imaging (venous ultrasonography , and/or Angio CT scan and/or angio MRI)

• Written inform consent

• Women of childbearing potential (WOCBP) are required to have a negative pregnancy test before treatment and must agree to maintain during treatment highly effective contraception (ie, abstinence, combined estrogen- and progestogen- containing hormonal contraception, ovulation inhibitors (Oral, Intravaginal, Transdermal); Progestogen-only hormonal contraception associated with inhibition of ovulation (Oral, Injectable, Implantable); Intrauterine device (IUD); Intrauterine hormone-releasing system (IUS); Bilateral tubal occlusion; Vasectomised partner).

• Affiliation to a social security system. Patients affiliated to universal medical coverage (CMU) are eligible for the study

Locations
Other Locations
France
CHU BORDEAUX Hôpital Saint-André
RECRUITING
Bordeaux
Ambroise Paré hospital AP-HP
RECRUITING
Boulogne-billancourt
CHU Caen
RECRUITING
Caen
Hopital Henri Mondor AP-HP
RECRUITING
Créteil
Chu de Grenoble
RECRUITING
Grenoble
Hôpital Bicêtre
RECRUITING
Le Kremlin-bicêtre
Hcl, Hopital de La Croix Rousse
RECRUITING
Lyon
Centre Hospitalier de Melun
RECRUITING
Melun
CHRU DE Nancy Hôpitaux de Brabois
RECRUITING
Nancy
Hôpital Hôtel-Dieu
RECRUITING
Nantes
Hopital Européen Georges Pompidou AP-HP
RECRUITING
Paris
Hôpital Lariboisière AP-HP
RECRUITING
Paris
Hôpital Saint Antoine AP-HP
RECRUITING
Paris
Hôpital Tenon AP-HP
RECRUITING
Paris
La Pitié Salpetriere hospital
RECRUITING
Paris
CHU Bordeaux- GHU SUD hôpital Haut-Lévêque
RECRUITING
Pessac
CHU DE ROUEN, Hôpital CHARLES NICOLLE
RECRUITING
Rouen
Contact Information
Primary
David Saadoun, MD PhD
david.saadoun@psl.aphp.fr
0142178042
Backup
Jérôme Lambert, MD PhD
jerome.lambert@u-paris.fr
0142499742
Time Frame
Start Date: 2025-06-24
Estimated Completion Date: 2028-06-24
Participants
Target number of participants: 134
Treatments
Experimental: Corticosteroids and Rivaroxaban
Active_comparator: Corticosteroids alone
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov