A Phase II, randomized, controlled, double blind study to evaluate the haemostatic efficacy and safety of TT-173 applied in the donor site of patients undergoing skin graft.

Thrombotargets Europe0 sitesAugust 8, 2013

Overview

No summary available.

Registry

who.int

Start Date

August 8, 2013

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Thrombotargets Europe

•1\. Informed consent signature before any study procedure.
•2\. Subjects who required skin graft.
•3\. Subjects older or equal than 18 years at informed consent signature time.
•4\. Subjects with a skin injury due to a burn or a traumatism which affects at least 20% of body surface.
•5\. Subjects with a platelet count no compatible with pathology.
•6\. Subjects with blood cells count no indicative of any situation mentioned in exclusion criteria.
•7\. Subjects with biochemical results no indicative of any situation mentioned in exclusion criteria.
•8\. Subjects with coagulation parameters no indicative of any situation mentioned in exclusión criteria.
•9\. Women potentially fertile must have a negative pregnancy test at inclusion time and agree to use a contraceptive method since informed consent signature until study completion.
•Are the trial subjects under 18? no

•1\. Subjects with personal or familiar history of abnormal bleeding episodes.
•2\. Subjects diagnosed of any kind of congenital or acquired coagulopathy.
•3\. Subjects with a cutaneous lesion which affects more than 20% of body surface.
•4\. Subjects affected of any hematologic pathology, cardiopathy, hepatopathy, renal insufficiency, chronic obstructive pulmonary disease, active oncologic process in the last three months or cerebral infarct.
•5\. Subjects who experienced an excessive bleeding after surgical procedures, deliveries or dental extractions.
•6\. Subjects affected for any acute infectious disease.
•7\. Subjects affected for any systemic disease which may contribute to worsening the outcome in case of adverse event (uncontrolled diabetes, uncontrolled hypertension or serious systemic disease).
•8\. Subjects in treatment with antiplatelet therapy one week and 24 hours prior to the surgery (AAS, triflusal, dipyridamole, clopidogrel, abciximab).
•9\. Subjects in treatment with oral anticoagulants (antivitamin K, antithrombin drugs and anti\-factor Xa), unfractionated heparin, aminocaproic acid and tranexamic acid one week and 24 hours prior to the surgery.
•10\. Subjects with known hypersensibility to yeast.