Resolution Enhancement by a Supplemental Open-Label Venoactive drug for Eight weeks in Deep Vein Thrombosis

Phase 3

Completed

• Conditions: Deep vein thrombosis; 10014523

• Registration Number: NL-OMON52521
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 44

Inclusion Criteria

Adult; acute deep vein thrombosis; objectively confirmed deep vein thrombosis
by duplex-echography; proximal deep vein thrombosis

Exclusion Criteria

Previous deep vein thrombosis; bilateral deep vein thrombosis; pre-existent
chronic venous insufficiency (CEAP >= C3); active malignancy; inflammatory
disease; pregnancy; indication for therapeutic thrombolysis; contra-indication
for a direct oral anticoagulant

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Presence of RVO in proximal venous segments determined by echography at 12<br /><br>weeks after DVT. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Levels of circulating makers (e.g. hs-CRP, IL-6, IL-8, IL-10, TNF-a, ICAM-1,<br /><br>VCAM-1, P-selectin, FVIII, MMP-1, MMP-8) at baseline, 1 week, 4 weeks, 8 weeks<br /><br>and 12 weeks after DVT.<br /><br><br /><br>Scores on PTS-characterizing clinical signs of the affected leg<br /><br>(circumferences, pitting-edema, hyperpigmentation, venous ectasia, redness,<br /><br>skin induration, pain during calf compression, venous ulcers) at baseline, 1<br /><br>week, 4 weeks, 8 weeks and 12 weeks after DVT.<br /><br><br /><br>Scores on PTS-characterizing symptoms of the affected leg (pain, cramps,<br /><br>heaviness, paresthesia, pruritus) at baseline, 4 weeks and 12 weeks after DVT.<br /><br><br /><br>Scores on quality of life at baseline, 4 weeks and 12 weeks.</p><br>