ACTRN12618000732280招募中4 期
Randomised Placebo Controlled Trial of Celecoxib for Acute Burn Inflammation and Fever
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 65 Years(—)
- 性别
- All
入选标准
- •Less than 48 hours from admission to the burns unit with acute burn injury
- •Outpatient booked for day of surgery admission for management of acute burn injury
排除标准
- •i. Regular NSAID use prior to injury (including any dose aspirin)
- •ii. Major burn with TBSA>20% or requiring admission to the intensive care unit
- •iii. Enrolment not considered in the patient’s best interest
- •iv. Previously enrolled in the CABIN Fever study
- •v. Participating in a competing interventional study
- •vi. Pregnancy or breast feeding
- •vii. NSAID or sulphonamide allergy
- •viii. Renal dysfunction (eGFR <60)
- •ix. Angina, myocardial infarction, heart failure (NYHA class II or greater: ordinary physical activity results in fatigue, palpitations or dyspnoea)
- •x. Previous history of peripheral arterial disease or stroke
- •xi. Current use of angiotensin converting enzyme inhibitor or angiotensin II receptor blocker
- •xii. Suspected or confirmed hepatic cirrhosis, portal hypertension or variceal bleeding
- •xiii. Current ALT 3x upper limit of normal or Bilirubin 2x upper limit of normal
- •xiv. Previous history of gastric ulcer or gastrointestinal bleeding
- •xv. Current systemic corticosteroid use
- •xvi. Suspected or confirmed haemophilia
- •xvii. Current use of anticoagulant medications including warfarin, new oral anticoagulants (NOACs) such as apixaban, dabigatran and rivaroxaban and treatment dose heparin
- •xviii. Suspected or confirmed thrombophilia or previous history of thromboembolism
研究者
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