Advanced Diagnostic Management of Suspected Recurrent Ipsilateral DVT With MRDTI

NCT ID: NCT02262052

Last Updated: 2019-09-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 305 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-26
• Study Completion Date: 2019-03-31

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.

Conditions

Deep Vein Thrombosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Phase 4 cohort study

MRDTI

Group Type: OTHER

MRDTI

Intervention Type: OTHER

MRDTI is primary diagnostic test for management of suspected ipsilateral DVT

Interventions

MRDTI

MRDTI is primary diagnostic test for management of suspected ipsilateral DVT

Intervention Type: OTHER

Eligibility 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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Trombosestichting Nederland

UNKNOWN

Sponsor Role: collaborator

Leiden University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Erik Klok

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

F.A. Klok Klok, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Thrombosis and Hemostasis, LUMC, Leiden

M.V. Huisman, Prof

Role: PRINCIPAL_INVESTIGATOR

Department of Thrombosis and Hemostasis, LUMC, Leiden

L.J.M. Kroft, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Radiology, LUMC, Leiden

Locations

Ottawa Hospital

Ottawa, , Canada

RAMBAM Healthcare center

Haifa, , Israel

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, , Netherlands

Ostfold Hospital Trust

Grålum, , Norway

Danderyds sjukhus

Stockholm, , Sweden

Countries

Canada; Israel; Netherlands; Norway; Sweden

References

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.

Reference Type: RESULT

PMID: 24928859 (View on PubMed)

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.

Reference Type: RESULT

PMID: 18433464 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32016390 (View on PubMed)

Other Identifiers

LeidenU

Identifier Type: -

Identifier Source: org_study_id