Advanced Diagnostic Management of Suspected Recurrent Ipsilateral DVT With MRDTI

NCT02262052 | Completed

• 1 other identifier: LeidenU
• Study Type: interventional
• Target: 305
• Locations: 5 countries
• Sites: 12

Brief Summary

The Theia-study is a prospective, multicenter, single-arm management (cohort) study. Consecutive patients with clinically suspected acute, recurrent, ipsilateral, proximal deep vein thrombosis (DVT) of the leg, who fulfil all the inclusion criteria and meet none of the exclusion criteria, are eligible for inclusion and will be managed according to the result of a magnetic resonance direct thrombus imaging (MRDTI) of the affected leg. The MRDTI is to be performed and adjudicated within 24 hours of study inclusion. The final treatment decision will be made based on this ruling of the MRDTI. In case of a positive MRDTI signal, patients will be treated with therapeutically dosed anticoagulants or modified in patients with a recurrent DVT on anticoagulant therapy. Patients with a negative MRDTI ruling will be left untreated, or treatment will be remained unadjusted if they are on anticoagulant treatment at inclusion. All patients with negative MRDTI will be subjected to a standardized compression ultrasonography (CUS) within 48 hours after initial presentation. The latter CUS serves as a reference test in case the patient returns with symptoms of ipsilateral recurrence in the future, and will not be used for management decisions at baseline. The study flowchart can be found in Appendix A. All patients will be followed for three months for the occurrence of acute recurrent venous thrombo-embolism (VTE). In case of suspected recurrent VTE, objective testing including either computed tomography pulmonary angiography (CTPA) for PE or CUS for DVT will be performed. Additionally, in case of a proven ipsilateral recurrent DVT during follow-up, MRDTI will be repeated.

Conditions

Deep Vein Thrombosis

Keywords

Deep vein thrombosis; Diagnostic management; Recurrent; MRI; Ipsilateral

Outcome Measures

Primary Outcomes (1)

• 3-month incidence of recurrent VTE in patients with negative MRDTI

  Primary outcome is subdivided in two main outcomes: 3-month incidence of recurrent VTE in 1) patients with negative MRDTI for both DVT and thrombophlebitis who were not treated with any anticoagulant during follow-up and 2) all patients with negative MRDTI for DVT; these recurrences need to be objectively confirmed by either CT (for acute PE), or CUS with the baseline CUS serving as reference.

  3-month follow-up

Secondary Outcomes (1)

• 3-month incidence of recurrent VTE in patients with normal D-dimer test and unlikely clinical probability according to the Wells clinical decision rule for DVT

  3-month follow-up

Other Outcomes (3)

• The feasibility of MRDTI in day to day clinical practice

  First 24 hours after presentation to the emergency ward (post-hoc analysis)

• Inter-observer variability of MRDTI

  After the study has been completed, all MRDTI studies will be re-evaluated (post-hoc analysis)

• a formal cost-effectiveness and cost-utility analysis

  This model will be based on the primary and secondary endpoints, scored after a follow-up period of 3 months (post-hoc analysis)

Study Arms (1)

Phase 4 cohort study

OTHER

MRDTI

Other: MRDTI

Interventions

MRDTI OTHER

MRDTI is primary diagnostic test for management of suspected ipsilateral DVT

Phase 4 cohort study

Eligibility Criteria

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

You may qualify if:

• Ability of subject to understand the character and individual consequences of this study;
• Signed and dated informed consent of the subject available before the start of any specific study procedures;
• Age ≥18 years;
• Suspected acute recurrent ipsilateral DVT, as defined by a documented prior objectivated episode of DVT in the same leg as current symptoms originate from

You may not qualify if:

• General contraindications for MRI: claustrophobia, pregnancy, intracranial vascular clips, any ferromagnetic implants, presence of a cardiac pacemaker or defibrillator, metallic splinters in the eye, any trauma or surgery which may have left ferromagnetic material in the body;
• CUS-proven acute symptomatic DVT within 6 months before current presentation;
• Onset of symptoms suggestive of acute recurrent DVT more than 10 days prior to presentation;
• Suspected acute PE;
• Hemodynamic instability at presentation (as a consequence of concurrent acute PE or otherwise);
• Medical or psychological condition that would not permit completion of the study or signing of informed consent, including life expectancy less than 3 months, or unwillingness to sign informed consent;
• Non-compliance or inability to adhere to treatment or follow-up visits.
• Note: \*From August 2015 onward, patients with suspected acute, recurrent, ipsilateral DVT on anticoagulant treatment were allowed in the study as they were found to represent a high proportion (30%) of the screened study population.

Sponsors & Collaborators

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

Study Sites (12)

Ottawa Hospital

Ottawa, Canada

Location

RAMBAM Healthcare center

Haifa, Israel

Location

AMC

Amsterdam, Netherlands

Location

Rijnstate

Arnhem, Netherlands

Location

Deventer Ziekenhuis

Deventer, Netherlands

Location

LUMC

Leiden, 2333 ZA, Netherlands

Location

HAGA

The Hague, Netherlands

Location

MCH Westeinde

The Hague, Netherlands

Location

Diakonessenhuis Utrecht

Utrecht, 3582 KE, Netherlands

Location

UMCU

Utrecht, Netherlands

Location

Ostfold Hospital Trust

Grålum, Norway

Location

Danderyds sjukhus

Stockholm, Sweden

Location

Related Publications (3)

• Tan M, Mol GC, van Rooden CJ, Klok FA, Westerbeek RE, Iglesias Del Sol A, van de Ree MA, de Roos A, Huisman MV. Magnetic resonance direct thrombus imaging differentiates acute recurrent ipsilateral deep vein thrombosis from residual thrombosis. Blood. 2014 Jul 24;124(4):623-7. doi: 10.1182/blood-2014-04-566380. Epub 2014 Jun 13.

  PMID: 24928859 RESULT

• Westerbeek RE, Van Rooden CJ, Tan M, Van Gils AP, Kok S, De Bats MJ, De Roos A, Huisman MV. Magnetic resonance direct thrombus imaging of the evolution of acute deep vein thrombosis of the leg. J Thromb Haemost. 2008 Jul;6(7):1087-92. doi: 10.1111/j.1538-7836.2008.02986.x. Epub 2008 Jul 1.

  PMID: 18433464 RESULT

• van Dam LF, Dronkers CEA, Gautam G, Eckerbom A, Ghanima W, Gleditsch J, von Heijne A, Hofstee HMA, Hovens MMC, Huisman MV, Kolman S, Mairuhu ATA, Nijkeuter M, van de Ree MA, van Rooden CJ, Westerbeek RE, Westerink J, Westerlund E, Kroft LJM, Klok FA; Theia Study Group. Magnetic resonance imaging for diagnosis of recurrent ipsilateral deep vein thrombosis. Blood. 2020 Apr 16;135(16):1377-1385. doi: 10.1182/blood.2019004114.

  PMID: 32016390 DERIVED

MeSH Terms

Conditions

Venous Thrombosis; Recurrence

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• F.A. Klok Klok, MD PhD

  Department of Thrombosis and Hemostasis, LUMC, Leiden

  PRINCIPAL INVESTIGATOR

• M.V. Huisman, Prof

  Department of Thrombosis and Hemostasis, LUMC, Leiden

  PRINCIPAL INVESTIGATOR

• L.J.M. Kroft, MD PhD

  Department of Radiology, LUMC, Leiden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: September 23, 2014
• First Posted: October 10, 2014
• Study Start: March 26, 2015
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: September 6, 2019

Record last verified: 2019-09

Locations

NL (8); CA (1); NO (1); IL (1); SE (1)