Determine the Haemostatic Efficacy of TT-173, Reducing the Bleeding Time in the Donor Site of Skin Grafting (EHTIC)

April 21, 2016 updated by: Thrombotargets Europe S.L

A Phase II Randomized, Controlled, Single Blind Study to Evaluate the Haemostatic Efficacy and Safety of TT-173 Applied in the Donor Site of Patients Undergoing Skin Graft

The purpose of this study is to determine the haemostatic efficacy of TT-173, reducing the bleeding time in the donor site of skin grafting.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

As the TT-113 has been cleared for use as a topical hemostatic agent, the proposed study will further investigate the safety and efficacy of TT-113 in the donor site of sking grafting

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
78

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Castelldefels, Barcelona, Spain, 08860
        • Thrombotargets Europe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects who signed the informed consent.
  • Subjects that have to undergo a skin graft.
  • Subjects of both sexes older than 18 years.
  • Subjects that present a burn or traumatic skin injury affecting less than 30% of corporal surface.
  • Subjects with a platelet count not compatible with pathology.
  • Subjects who present haemogram results not indicative of any of the situations mentioned in the exclusion criteria.
  • Subjects who present biochemical results not indicative of any of the situations mentioned in the exclusion criteria.
  • Subjects who present coagulation parameters not indicative of any of the situations mentioned in the exclusion criteria.
  • Women of childbearing age who take contraceptive measures and are willing to maintain them until the end of follow up of this study.
  • Women of childbearing age who present a negative test pregnancy at the moment of study inclusion

Exclusion Criteria:

  • -Subjects with personal or family history of abnormal hemorrhagic episodes.
  • Subjects affected of any kind of congenital or acquired coagulopathies.
  • Subjects that present a burn or traumatic skin injury affecting more than 31% of corporal surface.
  • Subjects affected of any blood, heart or liver disease, chronic renal failure, severe chronic obstructive pulmonary disease, active oncologic process in the past three months, diabetes type I or who has suffered a stroke.
  • Subjects who experienced excessive bleeding after surgical procedures, childbirth or tooth extraction.
  • Subjects affected by any acute infectious disease.
  • Subjects affected of any systemic disease that may worsen the prognosis if any adverse effect occurs (decompensated type 2 diabetes mellitus, uncontrolled hypertension or severe systemic disease).
  • Subjects who should take antiplatelet therapies one week before and 48 hours after the surgery (AAS, trifusal, dipiridamol, clopidogrel, abciximab).
  • Subjects with known hypersensitivity or allergy to any component of the drug.
  • Subjects who consume abuse drugs excluding cannabis and its derivatives.
  • Subjects who are unable to follow or understand properly the instructions and requirements of the study.
  • Subjects who are not free to give informed consent or who are mentally incapacitated to the discretion of investigators.
  • Subjects who participate or have participated in the past three months in another clinical trial with drug treatment.
  • Subjects that are the investigators, collaborators, nurses, center employees or any other person directly related to the development of the protocol.
  • Subjects who are positive to HIV or HCV serology, or who present active HBV infection.
  • Subjects who are pregnant or lactating.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: TT.173
It is applied directly to the bleeding of the donor site
Drug: TT-173
Bleeding of the lesion will be evaluated after each product application and will be recorded as bleeding vs. not bleeding. The product will be applied at 4 times for about 1 minute apart each application after skin graft obtention.
Other Names:
  • topical hemostatic agent
Placebo Comparator: placebo
It is applied directly to the bleeding of the donor site
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Reducing the bleeding time in the donor site of skin grafting
Time Frame: 10 min
10 min

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety and tolertability
Time Frame: 1 month
Number of Adverse Events
1 month
Systemic absorption of the product
Time Frame: 1 month
Cmax, Tmax, AUC and bioavailability
1 month
Immunogenicity
Time Frame: 1 month
Antibody concentration
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Thrombotargets Europe S.L

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Santiago Rojas, Manager, Thrombotargets Europe

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 21, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 16, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 22, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • THO-IM_01-CT
  • 2013-002784-25 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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