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Improved blood clot resolution by a drug for eight weeks

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26364
Enrollment
44
Registered
2020-02-09
Start date
2020-12-08
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute, proximal DVT of the lower extremity Deep vein thrombosis

Interventions

Treatment with Venoruton 500mg film-coated tablets oral twice daily for eight weeks after DVT

Sponsors

Maastricht University Medical Center (MUMC+)
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Presence of RVO, defined as a vein diameter =2mm on DUS during full compression.

Secondary

MeasureTime frame
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.

Contacts

Public ContactAaron F.J. Iding

Maastricht University Medical Center (MUMC+)

aaron.iding@mumc.nl+31622974916

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)