EUCTR2013-002784-25-ES进行中（未招募）不适用
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 个研究点开始时间: 2013年8月8日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.
研究者
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