ACTRN12609000764235招募中未知
Multi-centre randomised trial to evaluate the effect of early hypothermia on neurological function in patients with severe traumatic brain injury.
Australian and New Zealand Intensive Care-Research Centre, Monash University0 个研究点目标入组 500 人开始时间: 2009年9月3日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 500
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
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 60 Years（—）
- 性别
- All
入选标准
- •Pre-hospital Inclusion Criteria
- •*Blunt trauma with clinical diagnosis of severe Traumatic Brain Injury (TBI) and Glasgow Coma Scale <9
- •*Estimated age = 18 and < 60 years of age
- •*The patient is intubated or intubation is imminent
- •Emergency Dept Inclusion Criteria
- •*Blunt trauma with clinical diagnosis of severe TBI and GCS <9
- •*Estimated age > or = 18 and < 60 years of age
- •*The patient is intubated or intubation is imminent
排除标准
- •***********Pre-hospital Exclusion Criteria
- •Clinical diagnosis of drug or alcohol intoxication as predominant cause of coma
- •Randomisation unable to be performed within 3 hrs of estimated time of injury
- •Estimated transport time to study hospital >2.5hrs
- •Able to be intubated without drugs
- •Systolic BP <90mmHg
- •Heart rate > 120bpm
- •Cardiac arrest at the scene or in transit
- •GCS=3 and un-reactive pupils
- •Penetrating neck/torso injury
- •Known or obvious pregnancy
- •Receiving hospital is not a study site
- •Evidence of current anti-coagulant treatment
- •Known to be carer dependent due to a pre-existing neurological condition
- •***********Emergency Dept Exclusion Criteria
- •Clinical diagnosis of drug or alcohol intoxication as predominant cause of coma
- •Randomisation unable to be performed within 3 hrs of estimated time of injury
- •Able to be intubated without drugs
- •Persistent Systolic BP <90mmHg
- •GCS=3 + un-reactive pupils
- •Cardiac arrest at the scene or in transit
- •Clinically significant bleeding likely to require haemostatic intervention, for example:
- •Bleeding into the chest, abdomen or retro-peritoneum likely to require surgery +/- embolisation
- •**Pelvic fracture likely to require surgery +/- embolisation
- •**More than two long bone fractures requiring operative fixation
- •**Penetrating neck/torso injury
- •Positive urine or blood pregnancy test
- •Evidence of current anti-coagulant treatment
- •Known to be carer dependent due to a pre-existing neurological condition
- •In the treating clinician’s opinion, cooling” is not in the patient’s best interest
研究者
相似试验
进行中（未招募）
3 期
The DECRA trialACTRN12605000009617ational Trauma Research Institute, The Alfred165
进行中（未招募）
1 期
Trial to evaluate the efficacy of fentanyl pectin nasal spray (FPNS) versus Physician Choice (PC) - Usual Care (UC), in patients with head and neck cancer undergoing radiotherapy.Patients with head and neck cancer .MedDRA version: 21.1Level: PTClassification code 10067821Term: Head and neck cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2015-005110-30-ITFONDAZIONE IRCCS ISTITUTO NAZIONALE DEI TUMORI158
进行中（未招募）
1 期
A multicenter randomized trial to evaluate the efficacy of tocilizumab in patients with severe Coronavirus Disease 2019 (Covid-19) pneumonia failing glucocorticoids.polmonite severa da coronavirus 2019MedDRA version: 23.0Level: LLTClassification code 10053983Term: Corona virus infectionSystem Organ Class: 100000004862EUCTR2020-005291-35-ITAOU POLICLINICO DI MODENA640
招募中
1 期
A multicenter randomized trial to evaluate the efficacy of pioglitazone to improve renal outcome in ANCA-associated vasculitis - RENATOANCA-associated vasculitisCTIS2022-501057-36-00Assistance Publique Hopitaux De Paris126
进行中（未招募）
不适用
A multi-centre randomised study to evaluate the efficacy of Betaferon-interferon-beta-1b (IFNB-1B) 500 mcg therapy in the induction of tolerance to IFNB in MS patients with neutralising antibodies (NAbs) to IFNB-1a (Rebif) - Betaferon NaB Anergy StudyMultiple sclerosis (MS) is an inflammatory demyelinating disease of the central nervous system of unknown aetiology. It is the commonest cause of disability in young adults. The prevalence in the UK is approximately 125/100,000 of the population with an annual incidence of 6/100,000. Approximately 80,000 individuals are affected with MS in the UK.EUCTR2005-005751-18-GBCL Biomedicine R&D Unit100