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RECRUITING
NCT06390475

Optimizing Diagnosis of Splanchic Vein Thrombosis With MRDTI (Rhea)

Sponsor: Leiden University Medical Center

View on ClinicalTrials.gov

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

Interventions

DIAGNOSTIC_TEST

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