ACTRN12619000074190招募中2 期
A double-blind placebo-controlled study with an open-label pilot phase, assessing the efficacy, tolerability and safety of EU-C-001 in patients with moderate to severe traumatic brain injury
Eustralis Pharmaceuticals Ltd, trading as PresSura Neuro0 个研究点目标入组 65 人开始时间: 2019年1月21日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 65
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 70 Years（—）
- 性别
- All
入选标准
- •1. Male or female aged 18 to 70 years at the time the informed consent form is signed by either the patient or the patient’s legally authorized representative
- •2. Moderate to severe TBI due to blunt mechanism
- •3. Abnormal computerized tomography (CT) scan consistent with TBI due to blunt mechanism
- •4. Intracranial pressure monitor in situ, ICP >15 mm Hg at screening in the absence of potential external ICP stimuli, e.g., suctioning, coughing, and turning. The preferred method of ICP measurement is either intraventricular, intraparenchymal, or subdural, where possible
- •5. The GCS score at Screening is the most recent GCS score assessed at the hospital after resuscitation. If this is not available, the GCS score assessed by the ambulance personnel/paramedics prior to arrival at hospital will be used.
- •a. If the Total Score is assessable (range 3 to 15), a patient is eligible for inclusion if their score is in the range 3 to 12
- •b. If only the Eye and Motor scores are assessable (range 2 to 10), a patient is eligible for inclusion if their score is in the range 2 to 8
- •c. If only the Motor score is assessable (range 1 to 6), a patient is eligible for inclusion if their score is in the range 1 to 5
- •6. Onset of TBI within the last 72 hours
排除标准
- •1. Documented continuously elevated ICP >20 mm Hg for >12 hours after elevated ICP was first measured/observed
- •2. Use of an extraventricular drain for ICP control
- •3. Injury deemed non-survivable by study team
- •4. Penetrating brain injury
- •5. Bilateral dilated, unresponsive pupils
- •6. Imminent cranial or extracranial surgery
- •7. Patients in whom a subdural and/or extradural haematoma are present and are considered by the investigator to be the predominant cause of raised ICP
- •8. Concomitant use of thiopentone
- •9. Cervical spinal cord injury
- •10. Cardiopulmonary resuscitation performed by medical personnel/paramedics
- •11. Life-threatening systemic injuries, additional injuries, or conditions requiring medical treatment which would confound the assessment of the effects and/or safety of study medication
- •12. Morbid obesity with body mass index =40 kg/m2
- •13. Severe or unstable pre-existing respiratory and hemodynamic conditions
- •14. Hypoxemia (oxygen saturation <80%, measured by pulse oximetry)
- •15. Hypotension (sustained systolic blood pressure <70 mm Hg despite adequate volume resuscitation and vasopressors)
- •16. Status epilepticus
- •17. Pregnancy
- •18. Clinically significant anemia (hemoglobin <7 g/dL)
- •19. History of blood clotting disorder; exclude if international normalized ratio (INR) >1.5 and/or thrombocytes <50,000/µL
- •20. Moderate to severe renal impairment with estimated glomerular filtration rate <60 mL/min
- •21. Hepatic dysfunction with total bilirubin >2 × upper limit of normal and INR >1.5
- •22. Any major neurological or psychiatric disorder associated with significant impairment of cognitive function or motor function, e.g., Alzheimer’s disease with dementia, Parkinson’s disease, Huntington’s disease, alcohol or substance abuse
- •23. Participating in or has participated in other investigational interventional studies (drug or device) within the last 30 days (or 5 times the half-life of the previously administered investigational compound, whichever is longer) prior to study treatment initiation, with the exception of studies assessing approved medicinal products. Exception is made for co-enrolment in the PATCH study of tranexamic acid, allowing inclusion if treatment with EU-C-001 is initiated not earlier than 7 half-lives (14 hours) after the end of the last administration of study drug from the PATCH study.
- •24. Wearing an opt out bracelet or is known not to wish to participate in this type of study
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