Optimizing Diagnosis of Splanchic Vein Thrombosis With MRDTI (Rhea)

NCT06390475 | Recruiting

• 1 other identifier: P18.089
• Study Type: observational
• Target: 73
• Locations: 2 countries
• Sites: 3

Brief 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

Keywords

MR Direct Thrombus Imaging; Splanchnic vein thrombosis; Diagnostic management

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of MRDTI

  The primary objective of this study is to explore the diagnostic accuracy of MRDTI in the diagnostic management of acute and chronic SVT in a prospective diagnostic proof of concept study.

  This outcome will be analysed after adjudication, after the follow-up period of 3 months.

Secondary Outcomes (2)

• Optimizing MRDTI sequences

  This outcome will be analysed immediately after the inclusion of the first 3-5 acute SVT patients.

• Interobserver agreement

  This outcome will be analysed after adjudication, after the follow-up period of 3 months.

Study Arms (2)

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.

Diagnostic Test: MR Direct Thrombus Imaging (MRDTI)

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.

Diagnostic Test: MR Direct Thrombus Imaging (MRDTI)

Interventions

MR Direct Thrombus Imaging (MRDTI) DIAGNOSTIC_TEST

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.

Acute splanchnic thrombosis; Chronic splanhnic thrombosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a proven splanchnic vein thrombosis either acute or non-symptomatic chronic SVT defined by incident SVT with chronic thrombi on 2 serial imaging tests with at least 3 months interval.

You may qualify if:

• 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

You may not qualify if:

• MRI contra-indication (including but not limited to a cardiac pacemaker or subcutaneous defibrillator; vascular clips in the cerebral vessels; metal splinter in the eye, a hearing aid that cannot be removed; a neurostimulator that cannot be removed; a hydrocephalus pump)
• A medical condition, associated illness or co-morbid circumstances that precludes completion of the study procedures (MRI and 90-day follow-up assessment), including but not limited to lifeexpectancy less than 3 months, inability to lie flat, morbid obesity preventing use of MR and claustrophobia.
• Patients with decompensated liver disease with Child-Pugh class C cirrhosis (since MRDTI evaluation will be inadequate in these patients)
• Patients with suspected tumour thrombus

Sponsors & Collaborators

• Leiden University Medical Center: lead
• ISTH: collaborator
• Trombosestichting Nederland: collaborator

Study Sites (3)

Gemelli Hospital

Rome, 00136 RM, Italy

RECRUITING

Varese hospital

Varese, Italy

RECRUITING

Erasmus Medisch Centrum

Rotterdam, 3015 GD, Netherlands

RECRUITING

Related Publications (6)

• Riva N, Ageno W. Approach to thrombosis at unusual sites: Splanchnic and cerebral vein thrombosis. Vasc Med. 2017 Dec;22(6):529-540. doi: 10.1177/1358863X17734057.

  PMID: 29202678 BACKGROUND

• Dai J, Qi X, Peng Y, Hou Y, Chen J, Li H, Guo X. Association between D-dimer level and portal venous system thrombosis in liver cirrhosis: a retrospective observational study. Int J Clin Exp Med. 2015 Sep 15;8(9):15296-301. eCollection 2015.

  PMID: 26629017 BACKGROUND

• Riva N, Ageno W. Clinical manifestations and imaging tools in the diagnosis of splanchnic and cerebral vein thromboses. Thromb Res. 2018 Mar;163:252-259. doi: 10.1016/j.thromres.2017.06.030. Epub 2017 Jun 27.

  PMID: 28673473 BACKGROUND

• Cakmak O, Elmas N, Tamsel S, Demirpolat G, Sever A, Altunel E, Killi R. Role of contrast-enhanced 3D magnetic resonance portography in evaluating portal venous system compared with color Doppler ultrasonography. Abdom Imaging. 2008 Jan-Feb;33(1):65-71. doi: 10.1007/s00261-007-9229-x.

  PMID: 17440768 BACKGROUND

• Kreft B, Strunk H, Flacke S, Wolff M, Conrad R, Gieseke J, Pauleit D, Bachmann R, Hirner A, Schild HH. Detection of thrombosis in the portal venous system: comparison of contrast-enhanced MR angiography with intraarterial digital subtraction angiography. Radiology. 2000 Jul;216(1):86-92. doi: 10.1148/radiology.216.1.r00jl2386.

  PMID: 10887231 BACKGROUND

• Riva N, Ageno W, Schulman S, Beyer-Westendorf J, Duce R, Malato A, Santoro R, Poli D, Verhamme P, Martinelli I, Kamphuisen P, Dentali F; International Registry on Splanchnic Vein Thrombosis (IRSVT) study group. Clinical history and antithrombotic treatment of incidentally detected splanchnic vein thrombosis: a multicentre, international prospective registry. Lancet Haematol. 2016 Jun;3(6):e267-75. doi: 10.1016/S2352-3026(16)30020-5. Epub 2016 May 11.

  PMID: 27264036 BACKGROUND

Study Officials

• F.A. Klok, Prof.

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

S.N.M. ter Haar, MD

CONTACT

0031-71-52698096; s.n.m.ter_haar@lumc.nl

F.A. Klok, Prof.

CONTACT

0031-71-5263761; f.a.klok@LUMC.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: April 30, 2024
• Study Start: March 22, 2019
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: April 30, 2024

Record last verified: 2024-04

Locations

IT (2); NL (1)