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Advanced Diagnostic Management of Suspected Recurrent Ipsilateral DVT With MRDTI (Theia)

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ClinicalTrials.gov Identifier: NCT02262052
Recruitment Status : Recruiting
First Posted : October 10, 2014
Last Update Posted : March 7, 2018
Sponsor:
Collaborator:
Trombosestichting Nederland
Information provided by (Responsible Party):
Erik Klok, Leiden University Medical Center

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), 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. Patients with a negative MRDTI ruling 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

Detailed Description:
See below.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 305 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Advanced Diagnostic Management of Suspected Recurrent Ipsilateral Deep Vein Thrombosis of the Leg With Magnetic Resonance Direct Thrombus Imaging
Study Start Date : March 2015
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Phase 4 cohort study
MRDTI
Other: MRDTI
MRDTI is primary diagnostic test for management of suspected ipsilateral DVT




Primary Outcome Measures :
  1. 3-month incidence of recurrent VTE in non-treated patients [ Time Frame: 3-month follow-up ]
    The primary endpoint is the 3-month incidence of recurrent VTE in non-treated patients with normal MRDTI; these recurrences need to be objectively confirmed by either CT (for acute PE), or CUS with the baseline CUS serving as reference.


Secondary Outcome Measures :
  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 [ 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


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: F.A. Klok, MD PhD 0031-71-5263761 f.a.klok@LUMC.nl
Contact: M.V. Huisman, Prof. 0031-71-5263761 m.v.huisman@LUMC.nl

Locations
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Netherlands
AMC Recruiting
Amsterdam, Netherlands
Rijnstate Recruiting
Arnhem, Netherlands
Deventer Ziekenhuis Recruiting
Deventer, Netherlands
LUMC Recruiting
Leiden, Netherlands, 2333 ZA
Contact: Charlotte Dronkers, MD    0031715298096    c.e.a.dronkers@lumc.nl   
HAGA Recruiting
The Hague, Netherlands
MCH Westeinde Recruiting
The Hague, Netherlands
Diakonessenhuis Utrecht Recruiting
Utrecht, Netherlands, 3582 KE
Contact: Marcel van de Ree, MD PhD         
UMCU Recruiting
Utrecht, Netherlands
Sweden
Danderyds sjukhus Recruiting
Stockholm, Sweden
Sponsors and Collaborators
Leiden University Medical Center
Trombosestichting Nederland
Investigators
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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

Publications of Results:
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Responsible Party: Erik Klok, Dr, Leiden University Medical Center
ClinicalTrials.gov Identifier: NCT02262052     History of Changes
Other Study ID Numbers: LeidenU
First Posted: October 10, 2014    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018

Keywords provided by Erik Klok, Leiden University Medical Center:
Deep vein thrombosis
Diagnostic management
Recurrent
MRI
Ipsilateral

Additional relevant MeSH terms:
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Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases