Clinical trial NCT01960569: Topical r-Hirudin ( Thrombexx ) Efficacy in Treatment of Haematomas
Official title: Single Centre,Randomized,Phase IV Study to Assess the Topical r-Hirudin (Thrombexx)Efficacy in the Patients With Haematomas
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: r-Hirudin (Thrombexx) Efficacy in Treatment of Haematomas
Keywords: Thrombexx
Topical r-Hirudin
Efficacy
haematoma
Lead sponsor: MinaPharm Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2013-10-10
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 ) .

Eligibility 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.

Primary outcomes:
measure: Size of haematoma
timeFrame: 6 months
measure: Size of oedema
timeFrame: 6 months
measure: Severity of Pain
timeFrame: 6 months
measure: Change in Colour
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Prof. Mahmoud Hafez
Study officials:
affiliation: 6th October university
name: Mahmoud Hafez, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: 6th october university
name: Ahmed Moneer, Dr
role: STUDY_CHAIR
References:
citation: El-Mowafi H, El Araby A, Kandil Y, Zaghloul A. Randomized, double-blind, placebo-controlled, interventional phase IV investigation to assess the efficacy and safety of r-hirudin gel (1120I.U) in patients with hematomas. Res Pract Thromb Haemost. 2017 Nov 6;2(1):139-146. doi: 10.1002/rth2.12049. eCollection 2018 Jan.