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r-Hirudin (Thrombexx) for DVT Prophylaxis in Orthopedic Surgery
NCT05847205Phase 4
Key facts
- Status
- Unknown
- Start
- Nov 2022
- Primary completion
- Dec 2023
- Countries
- 1
- Sponsor
- Minapharm Pharmaceuticals
- Modality
- Recombinant Proteins and Enzymes
- Drugs
- recombinant hirudin
- Conditions
- deep vein thrombosis (DVT)pulmonary embolism (PE)
01
Overview
Phase 4, open-label, single-arm trial of recombinant hirudin in deep vein thrombosis (DVT) and pulmonary embolism (PE), sponsored by Minapharm Pharmaceuticals. Primary endpoint: New onset symptomatic thrombosis at 15 days. Status: unknown.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
r-Hirudin
Patients receiving r-Hirudin (Thrombexx) 15 mg BID s.c. for 15 days.
03
Who it enrols
Adult patients (>18 years, >60 kg) undergoing major orthopedic operations, excluding those with significant bleeding risk, pregnancy, recent hemorrhagic stroke, or need for other anticoagulants.
04
Endpoints
Primary
New onset symptomatic thrombosis
Secondary
Major bleeding
Adverse Events
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