Haemostatic effect in the donor site of patients undergoing skin graft. MedDRA version: 16.0 Level: HLGT Classification code 10022114 Term: Injuries NEC System Organ Class: 10022117 - Injury, poisoning and procedural complications
Conditions
Interventions
Product Name: TT-173
Product Code: TT-173
Pharmaceutical Form: Lyophilisate for suspension
INN or Proposed INN: Yeast-derived microvesicles containing recombinant Tissue Factor
CAS Number: NA
Current
Sponsors
Thrombotargets Europe
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 70 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: 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. 11. Subjects who consume abuse drugs other than cannabis and its derivatives. 12. Subjects unable to understand and follow study requirements. 13. Subjects unable of freely given the informed consent or, those who at investigator opinion are not completely reasoned. 14. Subjects who participated in a clinical trial with pharmacologic treatment in the three previous months. 15. Subjects related to the protocol performance such as investigators, collaborators, nursery staff or hospital employees. 16. Subjects with positive serology to HIV, HCV or active infection by HBV. 17. Pregnant or nursing women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the haemostatic efficacy of TT-173 when applied in the donor site of patients undergoing skin graft.;Secondary Objective: - To assess the systemic absorption of experimental product. - To assess tolerability and safety of TT-173 when applied on donor site of skin graft. - To assess immunogenicity of TT-173 when applied on donor site of skin graft.;Primary end point(s): Hemostasis time: define as the time necessary to stop the bleeding.;Timepoint(s) of evaluation of this end point: Every minute up to 10 minutes after the first product application. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Product systemic absorption: defined as detectable increase of tisular factor in blood at any evaluation time in comparison with basal level. - Donor site epithelization: defined as complete or uncomplete. - Adverse events incidence, severity and seriousness. - Product immunogenicity: defined as a antibodies reactive detectable increase at 35 ± 5 days to TT-173 product, tisular factor o hexa-histidines.;Timepoint(s) of evaluation of this end point: At the end of the study . | — |
Countries
Spain
Contacts
Public ContactJefe de Farmacología
Thrombotargets Europe
Outcome results
None listed