Overview
Topical r-Hirudin ( Thrombexx ) Efficacy in Treatment of Haematomas
Status:
Unknown status
Unknown status
Trial end date:
2014-04-01
2014-04-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
Single centre ,Phase IV , interventional, The study includes : 200 patients, 100 Patients will have Topical r-Hirudin (Thrombexx) and 100 patients will have placebo . The patients will be randomized to the active product (arm 1) or to placebo (arm 2). The study consists of 4 visits as the following : - Visit 1 : on day 1 to check patient eligibility and also for randomization . - Visit 2 : on day 4 to assess target parameters - Visit 3 : on day 8 to assess target parameters - Visit 4 : on day 16 to assess target parametersPhase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
MinaPharm PharmaceuticalsTreatments:
Hirudins
Criteria
Inclusion Criteria:- Age of patients between 20 and 60 years old.
- Patients with all types of haematoma.
Exclusion Criteria:
- Presence of infected wound requiring hospitalization or surgical intervention.
- History of allergy or hypersensitivity to any of the ingredients.
- Patients with coagulation disorders like haemophilia.
- Patients who are on anticoagulants like Warfarin and Acetylsalicylic acid .
- Patients who are taking digestive enzymes like alfa chemotrypsin.