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Optimizing Diagnosis of Splanchic Vein Thrombosis With MRDTI (Rhea)

NCT06390475 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 73

Last updated 2024-04-30

No results posted yet for this study

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.

Conditions

  • Splanchnic Vein Thrombosis

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.

Sponsors & Collaborators

  • ISTH

    collaborator UNKNOWN

  • Trombosestichting Nederland

    collaborator UNKNOWN

  • Leiden University Medical Center

    lead OTHER

Principal Investigators

  • F.A. Klok, Prof. · Study Principal Investigator

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-22
Primary Completion
2025-07-01
Completion
2025-07-01

Countries

  • Italy
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06390475 on ClinicalTrials.gov