Topical r-Hirudin ( Thrombexx ) Efficacy in Treatment of Haematomas

• Status: Unknown status
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: 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 parameters

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MinaPharm Pharmaceuticals
• Treatments: 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.