Advanced Diagnostic Management of Suspected Recurrent Ipsilateral DVT With MRDTI

Deep Vein Thrombosis Clinical Trial

— Theia  

Official title:

Advanced Diagnostic Management of Suspected Recurrent Ipsilateral Deep Vein Thrombosis of the Leg With Magnetic Resonance Direct Thrombus Imaging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02262052
• Other study ID #: LeidenU
• Status: Completed
• Phase: N/A
• Start date: March 26, 2015
• Est. completion date: March 2019

Study information

• Verified date: September 2019
• Source: Leiden University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

See below.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 305
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Ability of subject to understand the character and individual consequences of this study;

2. Signed and dated informed consent of the subject available before the start of any specific study procedures;

3. Age =18 years;

4. Suspected acute recurrent ipsilateral DVT, as defined by a documented prior objectivated episode of DVT in the same leg as current symptoms originate from

Exclusion Criteria:

1. 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;

2. CUS-proven acute symptomatic DVT within 6 months before current presentation;

3. Onset of symptoms suggestive of acute recurrent DVT more than 10 days prior to presentation;

4. Suspected acute PE;

5. Hemodynamic instability at presentation (as a consequence of concurrent acute PE or otherwise);

6. 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;

7. Non-compliance or inability to adhere to treatment or follow-up visits.

8. Patients with suspected acute, recurrent, ipsilateral DVT on therapeutic anticoagulant treatment > 48 hours at inclusion*

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.

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Thrombosis
• Venous Thrombosis

Intervention

Other:
• MRDTI
MRDTI is primary diagnostic test for management of suspected ipsilateral DVT

Locations

Country	Name	City	State
Canada	Ottawa Hospital	Ottawa
Israel	RAMBAM Healthcare center	Haifa
Netherlands	AMC	Amsterdam
Netherlands	Rijnstate	Arnhem
Netherlands	Deventer Ziekenhuis	Deventer
Netherlands	LUMC	Leiden
Netherlands	HAGA	The Hague
Netherlands	MCH Westeinde	The Hague
Netherlands	Diakonessenhuis Utrecht	Utrecht
Netherlands	UMCU	Utrecht
Norway	Ostfold Hospital Trust	Grålum
Sweden	Danderyds sjukhus	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Leiden University Medical Center	Trombosestichting Nederland

Countries where clinical trial is conducted

Canada,  Israel,  Netherlands,  Norway,  Sweden, 

References & Publications (2)

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. 201 — View Citation

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- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The feasibility of MRDTI in day to day clinical practice	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.	First 24 hours after presentation to the emergency ward (post-hoc analysis)
Other	Inter-observer variability of MRDTI	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.	After the study has been completed, all MRDTI studies will be re-evaluated (post-hoc analysis)
Other	a formal cost-effectiveness and cost-utility 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).	This model will be based on the primary and secondary endpoints, scored after a follow-up period of 3 months (post-hoc analysis)
Primary	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	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	the 3-month incidence of recurrent VTE in patients with low probability Wells score and a normal D-dimer test at baseline	3-month follow-up