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

MinaPharm Pharmaceuticals

Status and phase: Unknown; Phase 4

Conditions: r-Hirudin (Thrombexx) Efficacy in Treatment of Haematomas

Treatments: Drug: active product ( Thrombexx) assigned to arm 1; Other: Placebo assigned to arm 2

Study type: Interventional

Funder types: Industry

Identifiers

NCT01960569

Minpharm07052012

Details and patient eligibility

About

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

Full 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 ) .

Enrollment: 200 estimated patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

200 participants in 2 patient groups, including a placebo group

Arm 1 : active product (Thrombexx)

Active Comparator group

Description:

100 patients will have the active product(Thrombexx), their visits on days 1,4,8 and 16 for target parameters assessment

Treatment:

Drug: active product ( Thrombexx) assigned to arm 1

Arm 2 : Placebo

Placebo Comparator group

Description:

100 patients will have placebo , their visits on days 1,4,8 and 16 for target parameters assessment

Treatment:

Other: Placebo assigned to arm 2