Status:
COMPLETED
Advanced Diagnostic Management of Suspected Recurrent Ipsilateral DVT With MRDTI
Lead Sponsor:
Leiden University Medical Center
Collaborating Sponsors:
Trombosestichting Nederland
Conditions:
Deep Vein Thrombosis
Eligibility:
All Genders
18+ years
Phase:
NA
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) ...
Detailed Description
See below.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
March 26 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2019
Estimated Enrollment :
305 Patients enrolled
Trial Details
Trial ID
NCT02262052
Start Date
March 26 2015
End Date
March 1 2019
Last Update
September 6 2019
Active Locations (12)
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1
Ottawa Hospital
Ottawa, Canada
2
RAMBAM Healthcare center
Haifa, Israel
3
AMC
Amsterdam, Netherlands
4
Rijnstate
Arnhem, Netherlands