Optimizing Diagnosis of Splanchic Vein Thrombosis With MR Direct Thrombus Imaging, the Rhea Study

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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.

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

• Patients with confirmed acute SVT; definitions provided in paragraph 4.2 (Cases, group 1)

• Patients with confirmed non-symptomatic chronic SVT defined by incident SVT with chronic thrombi on 2 serial imaging tests with at least 3 months interval (controls, group 2)

• Aged 18 years and older

• Willing and able to give informed consent

Locations
Other Locations
Italy
Gemelli Hospital
RECRUITING
Rome
Varese hospital
RECRUITING
Varese
Netherlands
Erasmus Medisch Centrum
RECRUITING
Rotterdam
Contact Information
Primary
S.N.M. ter Haar, MD
s.n.m.ter_haar@lumc.nl
0031-71-52698096
Backup
F.A. Klok, Prof.
f.a.klok@LUMC.nl
0031-71-5263761
Time Frame
Start Date: 2019-03-22
Estimated Completion Date: 2025-07-01
Participants
Target number of participants: 73
Treatments
Chronic splanhnic thrombosis
Chronic Splanchnic vein thrombosis is defined by incident SVT with chronic thrombi on 2 serial imaging tests with an at least 3 months interval.
Acute splanchnic thrombosis
Acute splanchnic vein thrombosis is defined as acute symptomatic or acute incidental asymptomatic thrombosis in the mesenteric, splenic, portal or hepatic veins. Acute symptomatic thrombosis refers to acute onset (\< 2 week existent) of symptoms characteristic for SVT thrombosis (including but not limited to abdominal pain) with SVT confirmed with DUS, CTA or MRA, dependent on the anatomical location. Acute incidental asymptomatic thrombosis refers to an incidentally detected SVT with DUS, CTA or MRA, absent on previous diagnostic tests performed in the last 2 weeks before the new incidental finding, in patients without symptoms characteristic of SVT.
Sponsors
Collaborators: Trombosestichting Nederland, ISTH
Leads: Leiden University Medical Center

This content was sourced from clinicaltrials.gov