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临床试验/NCT03188913
NCT03188913Unknown不适用

Major Burns Coagulation and the Role of Factor XIII: A Descriptive Study

Hospital Universitari Vall d'Hebron Research Institute0 个研究点目标入组 20 人开始时间: 2017年6月19日最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
主要终点
Factor XIII

研究概览

简要总结

Prospective observational study in which FXIII levels and coagulation tests and cicatrization are measured during the 30 days after the thermal trauma.

详细描述

This is a prospective observational pilot study in which the levels of FXIII and coagulation, anticoagulation, fibrinolysis, endothelial tissue damage and cicatrization are at the arrival of the patient to hospital, 24 hours before the first surgical intervention, 24h After the first surgical intervention, at 7 days after the first intervention and at 30 days after the thermal trauma, in this moment the healing will also be evaluated. All burn patients who meet the proposed inclusion criteria will be included and entered into the Burn Unit of the Vall d'Hebron University Hospital from the start of the study until reaching a minimum of 20 cases or a temporary term of 2 years.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Burned patients with a burned body surface of 20% or more
  • Over 18 years of age

排除标准

  • ABSI (Abbreviated Burns Severity Index) greater than or equal to 12
  • Associated polytrauma
  • Coagulation deficit previously known
  • Treatment with anticoagulants
  • Electrocution burns
  • Admission into the unit after hour 6 after thermal trauma
  • The refusal of the patient, familiar or responsible to participate in the study

结局指标

主要结局

Factor XIII

时间窗: 30 days

Blood Coagulation Factor XIII levels

次要结局

  • Fibrinogen(30 days)
  • Prothrombin Time (PT)(30 days)
  • Thrombin Time (TT)(30 days)
  • Fibrin monomers(30 days)
  • Activated Partial Thromboplastin Time (APTT)(30 days)
  • Base Excess (BE)(30 days)
  • Lactate(30 days)
  • Factor XII(30 days)
  • Factor VIII(30 days)
  • Healing Vancouver test(30 days)
  • Factor von Willebrand(30 days)
  • Protein C(30 days)
  • Plasmin(30 days)
  • Plasminogen(30 days)
  • Antithrombin (AT)(30 days)
  • Heparan sulfate(30 days)
  • Syndecan 1(30 days)
  • Healing POSAS test(30 days)
  • Surgical bleeding survey(10 days)
  • Alpha-2-antiplasmin(30 days)
  • Tewamether moisture titration(30 days)
  • Surface debrided(10 days)
  • Reintervention due to bleeding(11 days)
  • Surgery Bleeding(15 days)

研究者

申办方类型
Other
责任方
Sponsor

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