Advanced Diagnostic Management of Suspected Recurrent Ipsilateral DVT With MRDTI (Theia)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02262052|
Recruitment Status : Completed
First Posted : October 10, 2014
Last Update Posted : September 6, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Deep Vein Thrombosis||Other: MRDTI||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||305 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Advanced Diagnostic Management of Suspected Recurrent Ipsilateral Deep Vein Thrombosis of the Leg With Magnetic Resonance Direct Thrombus Imaging|
|Actual Study Start Date :||March 26, 2015|
|Actual Primary Completion Date :||March 2019|
|Actual Study Completion Date :||March 2019|
Phase 4 cohort study
MRDTI is primary diagnostic test for management of suspected ipsilateral DVT
- 3-month incidence of recurrent VTE in patients with negative MRDTI [ Time Frame: 3-month follow-up ]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 incidence of recurrent VTE in patients with normal D-dimer test and unlikely clinical probability according to the Wells clinical decision rule for DVT [ Time Frame: 3-month follow-up ]the 3-month incidence of recurrent VTE in patients with low probability Wells score and a normal D-dimer test at baseline
- The feasibility of MRDTI in day to day clinical practice [ Time Frame: First 24 hours after presentation to the emergency ward (post-hoc analysis) ]The feasibility of MRDTI in day to day clinical practice: percentage of eligible patients that had to be excluded due to logistic reasons such as unavailability of MRDTI within 24 hours of presentation.
- Inter-observer variability of MRDTI [ Time Frame: After the study has been completed, all MRDTI studies will be re-evaluated (post-hoc analysis) ]The inter-observer variability of MRDTI in daily clinical practice: all MRDTI scans will be review post-hoc by two independent experts to determine the alpha statistic between the readings in clinical practice and that by experts.
- a formal cost-effectiveness and cost-utility analysis [ Time Frame: This model will be based on the primary and secondary endpoints, scored after a follow-up period of 3 months (post-hoc analysis) ]A Markov model will be developed to estimate the cost-effectiveness MRDTI versus ultrasonography. The model will follow the patients through the course of disease in a maximum of two three-month cycles, and will include all relevant clinical outcomes and incorporated health states stratified by diagnostic management. Clinical events included in the model are fatal PE, recurrent VTE, major bleeds and clinically relevant non-major. The model includes clinical and cost outcomes, along with incremental cost-effectiveness ratios (ICERs) and net monetary benefits (NMBs).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02262052
|RAMBAM Healthcare center|
|Leiden, Netherlands, 2333 ZA|
|The Hague, Netherlands|
|The Hague, Netherlands|
|Utrecht, Netherlands, 3582 KE|
|Ostfold Hospital Trust|
|Principal Investigator:||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|