Resolution Enhancement by a Supplemental Obstruction Lessening Venoactive Drug for Eight Weeks in Deep Vein Thrombosis

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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-thrombotic syndrome (PTS). Based on these results, the investigators will estimate its potential as a preventive therapy for PTS.

Eligible consenting patients who develop an acute, objectively confirmed DVT will be randomized and equally allocated to two trial arms, either the treatment group (Venoruton tablet 500 mg twice daily) or the control group (usual care). The pilot trial consists of 5 study contacts over 12 weeks at which outcome assessment is performed: inclusion, 1 week, 4 weeks, 8 weeks, 12 weeks. Treatment allocation is masked for outcome assessors, but not for patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maastricht University Medical Center
• Collaborator: Netherlands Thrombosis Foundation
• Treatments: Troxerutin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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