Improved blood clot resolution by a drug for eight weeks
Phase 3
Completed
- Conditions
- <p>Acute, proximal DVT of the lower extremity</p>Deep vein thrombosis10014523
- Registration Number
- NL-OMON26364
- Lead Sponsor
- Maastricht University Medical Center (MUMC+)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 44
Inclusion Criteria
Adult ; Objectively confirmed DVT of lower extremity by DUS; Proximal localisation of DVT; Acute onset of DVT (symptoms for = 7 days at presentation); Willing and able to give written consent
Exclusion Criteria
Previous DVT; Bilateral DVT; Pre-existent chronic venous insufficiency; Active malignancy or inflammatory disease; Pregnancy; Indication for therapeutic thrombolysis; Contra-indication for DOAC
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Presence of RVO, defined as a vein diameter =2mm on DUS during full compression.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Circulating biomarkers levels of inflammation, cell adhesion and remodeling; Severity of PTS-characterizing clinical signs and symptoms (Villalta-scale + leg circumferences); QoL scores (VEINS-QOL/Sym, SF-36, EQ-5D). Additional assessments are medication adherence (MMAS-8), compliance to ECT, and pill count of Venoruton (if applicable) and DOAC.</p><br>