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临床试验/EUCTR2016-002769-72-DK
EUCTR2016-002769-72-DK进行中(未招募)1 期

DEXRAR: DEXamethasone in Revision ARthroplasty: A randomised, blinded, 2-group clinical trial

æstved Hospital0 个研究点开始时间: 2016年7月6日最近更新:
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试验速览

阶段
1 期
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

  • Scheduled for unilateral, revision-TKA: Total and major partial revisions were included, i.e. revisions including the femoral and/or the tibial component(s).
  • ASA 1- 3.
  • BMI > 18 and < 45
  • Women in the fertile age (i.e. until one year after menopause) must have negative urine HCG pregnancy test
  • Patients who gave their written informed consent to participating in the trial after having fully understood the contents of the protocol and restrictions.
  • 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 28
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 80

排除标准

  • Patients who cannot cooperate with the trial.
  • Concomitant participation in another trial involving medication
  • Patients who cannot understand or speak Danish.
  • Patients with allergy to medicines used in the trial.
  • Contraindications against NSAID, for example previous ulcer, heart failure, liver failure, or renal failure (eGRF < 60 ml/kg/1,73m2), known thrombocytopenia (<100 mia/L)
  • Patients suffering from alcohol and/or drug abuse – based on the investigator's judgement.

研究者

发起方
æstved Hospital

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