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Optimizing Diagnosis of Splanchic Vein Thrombosis With MRDTI (Rhea)
Sponsor: Leiden University Medical Center
Summary
The Rhea-study is a multicenter prospective diagnostic proof-of-concept study There is an unquestionable need for improved diagnostic approaches for (incidental) SVT. The researchers plan to evaluate the MRDTI technique, that has been shown to be accurate in other settings of difficult-to-diagnosis venous thrombosis, for the notoriously challenging diagnosis of incidental SVT. This study targets an important unmet need and will provide the basis for precision medicine for patients with SVT in the near future, i.e. the possibility of assessment of the age of the thrombus in patients with incidental SVT, which is of utmost importance for determination of the indication for anticoagulant therapy. If this hypothesis is proven true, i.e. sensitivity of MRDTI for SVT is indeed \>90%, the investigators will proceed with performing a randomized controlled outcome study in which patients with possible/probable chronic SVT with normal MRDTI test results and no other indications for anticoagulant therapy. These patients will be randomized between active therapeutically dosed anticoagulation versus no anticoagulation, to compare clinical outcome with regard to the occurrence of venous thromboembolism and/or Progressive symptomatic SVT as well as major bleeding.
Official title: Optimizing Diagnosis of Splanchic Vein Thrombosis With MR Direct Thrombus Imaging, the Rhea Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
73
Start Date
2019-03-22
Completion Date
2025-07-01
Last Updated
2024-04-30
Healthy Volunteers
No
Conditions
Interventions
MR Direct Thrombus Imaging (MRDTI)
Both groups will get the same MRDTI, the study is a proof-of-concept study to investigate if MRDTI can reliable distinguish between acute and chronic splanchnic thrombosis.
Locations (3)
Gemelli Hospital
Rome, Italy
Varese hospital
Varese, Italy
Erasmus Medisch Centrum
Rotterdam, Netherlands