Topical r-Hirudin ( Thrombexx ) Efficacy in Treatment of Haematomas
- Conditions
- r-Hirudin (Thrombexx) Efficacy in Treatment of Haematomas
- Interventions
- Drug: active product ( Thrombexx) assigned to arm 1Other: Placebo assigned to arm 2
- Registration Number
- NCT01960569
- Lead Sponsor
- MinaPharm Pharmaceuticals
- Brief 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
- Detailed Description
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
* Study objective :Assessment the Efficacy of Topical r-Hirudin in treatment of haematomas ,also in resolving of the associated oedema
* Study duration : 6 months
* Selection of trial subjects:
Inclusion Criteria :
1. Age of patients between 20 and 60 years old.
2. Patients with all types of haematomas.
Exclusion Criteria:
1. Presence of infected wound requiring hospitalization or surgical intervention.
2. History of allergy or hypersensitivity to any of the ingredients.
3. Patients with coagulation disorders like haemophilia.
4. Patients who are on anticoagulants like Warfarin and Acetylsalicylic acid .
5. Patients who are taking digestive enzymes like alfa chemotrypsin.
* Target parameters :
1.Size of haematoma.( Measured by ruler) , The ruler will measure the longest 2 intersecting line.
2.Size of oedema : by measurement of oedema circumference
3.Pain (by Vas score).
4.Change in colour ( by colour grade scale ) .
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- Age of patients between 20 and 60 years old.
- Patients with all types of haematoma.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 : active product (Thrombexx) active product ( Thrombexx) assigned to arm 1 100 patients will have the active product(Thrombexx), their visits on days 1,4,8 and 16 for target parameters assessment Arm 2 : Placebo Placebo assigned to arm 2 100 patients will have placebo , their visits on days 1,4,8 and 16 for target parameters assessment
- Primary Outcome Measures
Name Time Method Size of oedema 6 months Assessment the size of oedema will be by measurement the circumference in unit centimeter(cm).
Severity of Pain 6 months Assessment of pain severity will be by Vas score
Size of haematoma 6 months Assessment the size of haematoma will be by ruler with unit centimeter(cm) , The ruler will measure the longest 2 intersecting line.
Change in Colour 6 months Assessment of colour will be by colour grade scale , A=Bluish red , B=Blue ,C= Faint
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Prof. Mahmoud Hafez
🇪🇬Cairo, Egypt