Deep Vein ThrombosisTheiaNCT02262052
Advanced Diagnostic Management of Suspected Recurrent Ipsilateral DVT With MRDTI
A study testing MRDTI in people with Deep Vein Thrombosis, run by Leiden University Medical Center at 12 sites in 5 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Vein Thrombosis
- What is being tested?
- MRDTI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 305 participants
- Where
- 12 sitesin 5 countries
- Study dates
- 26 Mar 2015to Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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.
Trial locations and contacts
12 sites in 5 countries.
12 sites in 5 countries
Netherlands8 sites
AMC
Amsterdam
Rijnstate
Arnhem
Deventer Ziekenhuis
Deventer
LUMC
Leiden, 2333 ZA
HAGA
The Hague
MCH Westeinde
The Hague
Diakonessenhuis Utrecht
Utrecht, 3582 KE
UMCU
Utrecht
About this study
Official title: Advanced Diagnostic Management of Suspected Recurrent Ipsilateral Deep Vein Thrombosis of the Leg With Magnetic Resonance Direct Thrombus Imaging
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.
Read the detailed description
See below.
- Conditions
- Deep Vein Thrombosis
- Being tested
- MRDTI
- Keywords
- Deep vein thrombosis, Diagnostic management, Recurrent, MRI, Ipsilateral
- Medical subject headings
- Venous Thrombosis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRDTIOther
MRDTI is primary diagnostic test for management of suspected ipsilateral DVT
| Study group | Role | What they receive |
|---|---|---|
| Phase 4 cohort study | Other | MRDTI Receives: Other: MRDTI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
the 3-month incidence of recurrent VTE in patients with low probability Wells score and a normal D-dimer test at baseline
Measured: 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2014 (estimated)
- Study start26 Mar 2015
- Primary completionMar 2019
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Deep Vein ThrombosisStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 305 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Trombosestichting Nederland
- Responsible party
- Principal investigator, Erik Klok, Leiden University Medical Center
- Investigators
- F.A. Klok Klok, MD PhD, Principal investigator, Department of Thrombosis and Hemostasis, LUMC, LeidenM.V. Huisman, Prof, Principal investigator, Department of Thrombosis and Hemostasis, LUMC, LeidenL.J.M. Kroft, MD PhD, Principal investigator, Department of Radiology, LUMC, Leiden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02262052
- Sponsor's protocol ID
- LeidenU
- Acronym
- Theia
- Status last verified
- Sep 2019
- First submitted
- 23 Sep 2014
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24928859Westerbeek 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.
PubMed 18433464van 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.
PubMed 32016390
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Diagnostic Management of Suspected Recurrent Ipsilateral Deep Vein Thrombosis of the Leg With Magnetic Resonance Direct Thrombus Imaging
- ClinicalTrials.gov ID
- NCT02262052
- Acronym / sponsor ID
- Theia / LeidenU
- Conditions
- Deep Vein Thrombosis
- Keywords
- Deep vein thrombosis, Diagnostic management, Recurrent, MRI, Ipsilateral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 305 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- Trombosestichting Nederland
- Study start
- 26 Mar 2015 (actual)
- Primary completion
- Mar 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 10 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
See below.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phase 4 cohort study | Other | Other: MRDTIMRDTI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRDTIMRDTI is primary diagnostic test for management of suspected ipsilateral DVT | Other | Phase 4 cohort study |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
- Results publication: PubMed 24928859Tan 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.
- Results publication: PubMed 18433464Westerbeek 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.
- Derived from this study: PubMed 32016390van 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
F.A. Klok Klok, MD PhD principal investigator
Department of Thrombosis and Hemostasis, LUMC, Leiden
M.V. Huisman, Prof principal investigator
Department of Thrombosis and Hemostasis, LUMC, Leiden
L.J.M. Kroft, MD PhD principal investigator
Department of Radiology, LUMC, Leiden
12 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRDTI in people with Deep Vein Thrombosis, run by Leiden University Medical Center at 12 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Netherlands, Canada, Israel, Norway, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-month incidence of recurrent VTE in patients with negative MRDTI (time frame: 3-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02262052, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2019.