We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01960569
Recruitment Status : Unknown
Verified October 2013 by MinaPharm Pharmaceuticals.
Recruitment status was:  Recruiting
First Posted : October 10, 2013
Last Update Posted : October 10, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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

Condition or disease Intervention/treatment Phase
r-Hirudin (Thrombexx) Efficacy in Treatment of Haematomas Drug: active product ( Thrombexx) assigned to arm 1 Other: Placebo assigned to arm 2 Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Single Centre,Randomized,Phase IV Study to Assess the Topical r-Hirudin (Thrombexx)Efficacy in the Patients With Haematomas
Study Start Date : October 2013
Estimated Primary Completion Date : January 2014
Estimated Study Completion Date : April 2014
Arms and Interventions

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 Name: 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


Outcome Measures

Primary Outcome Measures :
  1. Size of haematoma [ Time Frame: 6 months ]
    Assessment the size of haematoma will be by ruler with unit centimeter(cm) , The ruler will measure the longest 2 intersecting line.

  2. Size of oedema [ Time Frame: 6 months ]
    Assessment the size of oedema will be by measurement the circumference in unit centimeter(cm).

  3. Severity of Pain [ Time Frame: 6 months ]
    Assessment of pain severity will be by Vas score

  4. Change in Colour [ Time Frame: 6 months ]
    Assessment of colour will be by colour grade scale , A=Bluish red , B=Blue ,C= Faint


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01960569


Contacts
Contact: Mahmoud Hafez, Professor 002 0100 7566299 mhafez@msn.com
Contact: Moustafa Sameer, Dr 002 0100 6016 212 msameer@minapharm.com

Locations
Egypt
Prof. Mahmoud Hafez Recruiting
Cairo, Egypt
Contact: Ahmed Moneer, Dr    002 0100 8608676    dr_ahmedmoneer@yahoo.com   
Principal Investigator: Mahmoud Hafez, Professor         
Sponsors and Collaborators
MinaPharm Pharmaceuticals
Investigators
Principal Investigator: Mahmoud Hafez, Professor 6th October university
Study Chair: Ahmed Moneer, Dr 6th october university
More Information

Responsible Party: MinaPharm Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01960569     History of Changes
Other Study ID Numbers: Minpharm07052012
First Posted: October 10, 2013    Key Record Dates
Last Update Posted: October 10, 2013
Last Verified: October 2013

Keywords provided by MinaPharm Pharmaceuticals:
Thrombexx
Topical r-Hirudin
Efficacy
haematoma

Additional relevant MeSH terms:
Hematoma
Hemorrhage
Pathologic Processes
Hirudins
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents