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

Single Centre,Randomized,Phase IV Study to Assess the Topical r-Hirudin (Thrombexx)Efficacy in the Patients With Haematomas

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 Overview

• Status: Unknown
• Conditions: r-Hirudin (Thrombexx) Efficacy in Treatment of Haematomas
• Intervention / Treatment: Drug: active product ( Thrombexx) assigned to arm 1; Other: Placebo assigned to arm 2

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 ) .

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Mahmoud Hafez, Professor; Phone Number: 002 0100 7566299; Email: mhafez@msn.com
• Study Contact Backup: Name: Moustafa Sameer, Dr; Phone Number: 002 0100 6016 212; Email: msameer@minapharm.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Prof. Mahmoud Hafez
    • Contact: Ahmed Moneer, Dr; Phone Number: 002 0100 8608676; Email: dr_ahmedmoneer@yahoo.com
    • Principal Investigator: Mahmoud Hafez, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Arm 1 : active product (Thrombexx); 100 patients will have the active product(Thrombexx), their visits on days 1,4,8 and 16 for target parameters assessment	Drug: active product ( Thrombexx) assigned to arm 1; Dispense 2-3 cm of cream or gel, 2-3 times per day and carry out a light massage until complete; Other Names: Topical r-Hirudin
PLACEBO_COMPARATOR: Arm 2 : Placebo; 100 patients will have placebo , their visits on days 1,4,8 and 16 for target parameters assessment	Other: Placebo assigned to arm 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Size of haematoma	Assessment the size of haematoma will be by ruler with unit centimeter(cm) , The ruler will measure the longest 2 intersecting line.	6 months
Size of oedema	Assessment the size of oedema will be by measurement the circumference in unit centimeter(cm).	6 months
Severity of Pain	Assessment of pain severity will be by Vas score	6 months
Change in Colour	Assessment of colour will be by colour grade scale , A=Bluish red , B=Blue ,C= Faint	6 months

Collaborators and Investigators

• Sponsor: MinaPharm Pharmaceuticals
• Investigators: Principal Investigator: Mahmoud Hafez, Professor, 6th october university; Study Chair: Ahmed Moneer, Dr, 6th october university

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (ANTICIPATED): January 1, 2014
• Study Completion (ANTICIPATED): April 1, 2014

Study Registration Dates

• First Submitted: October 7, 2013
• First Submitted That Met QC Criteria: October 9, 2013
• First Posted (ESTIMATE): October 10, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): October 10, 2013
• Last Update Submitted That Met QC Criteria: October 9, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: Efficacy; haematoma; Thrombexx; Topical r-Hirudin
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Hematoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Fibrinolytic Agents; Fibrin Modulating Agents; Protease Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Hirudins
• Other Study ID Numbers: Minpharm07052012