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

Primary Purpose

Deep Vein Thrombosis

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
MRDTI
Sponsored by
Leiden University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Deep Vein Thrombosis focused on measuring Deep vein thrombosis, Diagnostic management, Recurrent, MRI, Ipsilateral

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ottawa Hospital
  • RAMBAM Healthcare center
  • AMC
  • Rijnstate
  • Deventer Ziekenhuis
  • LUMC
  • HAGA
  • MCH Westeinde
  • Diakonessenhuis Utrecht
  • UMCU
  • Ostfold Hospital Trust
  • Danderyds sjukhus

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Phase 4 cohort study

Arm Description

MRDTI

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
September 23, 2014
Last Updated
September 4, 2019
Sponsor
Leiden University Medical Center
Collaborators
Trombosestichting Nederland
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1. Study Identification

Unique Protocol Identification Number
NCT02262052
Brief Title
Advanced Diagnostic Management of Suspected Recurrent Ipsilateral DVT With MRDTI
Acronym
Theia
Official Title
Advanced Diagnostic Management of Suspected Recurrent Ipsilateral Deep Vein Thrombosis of the Leg With Magnetic Resonance Direct Thrombus Imaging
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
March 26, 2015 (Actual)
Primary Completion Date
March 2019 (Actual)
Study Completion Date
March 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Leiden University Medical Center
Collaborators
Trombosestichting Nederland

4. Oversight

Data Monitoring Committee
No

5. Study Description

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) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Vein Thrombosis
Keywords
Deep vein thrombosis, Diagnostic management, Recurrent, MRI, Ipsilateral

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
305 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phase 4 cohort study
Arm Type
Other
Arm Description
MRDTI
Intervention Type
Other
Intervention Name(s)
MRDTI
Intervention Description
MRDTI is primary diagnostic test for management of suspected ipsilateral DVT
Primary Outcome Measure Information:
Title
3-month incidence of recurrent VTE in patients with negative MRDTI
Description
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.
Time Frame
3-month follow-up
Secondary Outcome Measure Information:
Title
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
Description
the 3-month incidence of recurrent VTE in patients with low probability Wells score and a normal D-dimer test at baseline
Time Frame
3-month follow-up
Other Pre-specified Outcome Measures:
Title
The feasibility of MRDTI in day to day clinical practice
Description
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.
Time Frame
First 24 hours after presentation to the emergency ward (post-hoc analysis)
Title
Inter-observer variability of MRDTI
Description
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.
Time Frame
After the study has been completed, all MRDTI studies will be re-evaluated (post-hoc analysis)
Title
a formal cost-effectiveness and cost-utility analysis
Description
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).
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
F.A. Klok Klok, MD PhD
Organizational Affiliation
Department of Thrombosis and Hemostasis, LUMC, Leiden
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
M.V. Huisman, Prof
Organizational Affiliation
Department of Thrombosis and Hemostasis, LUMC, Leiden
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
L.J.M. Kroft, MD PhD
Organizational Affiliation
Department of Radiology, LUMC, Leiden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ottawa Hospital
City
Ottawa
Country
Canada
Facility Name
RAMBAM Healthcare center
City
Haifa
Country
Israel
Facility Name
AMC
City
Amsterdam
Country
Netherlands
Facility Name
Rijnstate
City
Arnhem
Country
Netherlands
Facility Name
Deventer Ziekenhuis
City
Deventer
Country
Netherlands
Facility Name
LUMC
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Facility Name
HAGA
City
The Hague
Country
Netherlands
Facility Name
MCH Westeinde
City
The Hague
Country
Netherlands
Facility Name
Diakonessenhuis Utrecht
City
Utrecht
ZIP/Postal Code
3582 KE
Country
Netherlands
Facility Name
UMCU
City
Utrecht
Country
Netherlands
Facility Name
Ostfold Hospital Trust
City
Grålum
Country
Norway
Facility Name
Danderyds sjukhus
City
Stockholm
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
24928859
Citation
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.
Results Reference
result
PubMed Identifier
18433464
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.1538-7836.2008.02986.x. Epub 2008 Jul 1.
Results Reference
result
PubMed Identifier
32016390
Citation
van 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.
Results Reference
derived

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Advanced Diagnostic Management of Suspected Recurrent Ipsilateral DVT With MRDTI

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