Status:
COMPLETED
Resolution Enhancement by a Supplemental Obstruction Lessening Venoactive Drug for Eight Weeks in Deep Vein Thrombosis
Lead Sponsor:
Maastricht University Medical Center
Collaborating Sponsors:
Netherlands Thrombosis Foundation
Conditions:
Deep Vein Thrombosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The RESOLVE-DVT study is a randomized single-center pilot study to determine the effects of hydroxyethylrutoside (Venoruton) on aspects of deep vein thrombosis (DVT) resolution associated with post-th...
Detailed Description
Rationale: After a DVT, one in three patients develops PTS of the affected leg, despite anticoagulant treatment and elastic compression therapy (ECT) in the acute phase of DVT. Considering the major s...
Eligibility Criteria
Inclusion
- Adult, defined as ≥ 18 years of age
- Objectively confirmed DVT by DUS
- Proximal DVT, defined as iliofemoropopliteal venous thrombosis
- Acute DVT, defined as having symptoms for ≤ 7 days at presentation
- Willing and able to give written informed consent
Exclusion
- Previous DVT
- Bilateral DVT
- Pre-existent chronic venous insufficiency (CEAP-criteria C ≥ 3)
- Active malignancy, inflammatory disease (e.g. rheumatoid arthritis), or immunosuppressive therapy
- Current pregnancy or breast feeding
- Indication for therapeutic thrombolysis
- Contra-indication for DOAC
Key Trial Info
Start Date :
December 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 28 2023
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT04670432
Start Date
December 8 2020
End Date
November 28 2023
Last Update
March 1 2024
Active Locations (1)
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1
Maastricht University Medical Center
Maastricht, Limburg, Netherlands, 6229 HX