EUCTR2017-004890-15-GB进行中（未招募）1 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 - PANGEA
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 45
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
- •1. Male or female aged 18 to 65 years at the time the ICF is signed, or obtained remotely, by either the patient or the patient’s legally authorized representative
- •2. Moderate to severe TBI due to blunt mechanism
- •3. Abnormal CT scan result consistent with TBI due to blunt mechanism
- •4. Intracranial pressure monitor in situ, ICP >20 mm Hg at screening in the absence of potential external ICP stimuli, e.g., suctioning, coughing, and turning. ICP at start of first infusion of study drug = 18 mmHg. 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
- •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 45
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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 (EVD) 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. Concomitant use of thiopentone
- •8. Cervical spinal cord injury
- •9. Cardiopulmonary resuscitation performed
- •10. 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
- •11. Morbid obesity with body mass index =40 kg/m2
- •12. Severe or unstable pre-existing respiratory and hemodynamic conditions
- •13. Hypoxemia (oxygen saturation <80%, measured by pulse oximetry)
- •14. Hypotension (sustained systolic blood pressure <70 mm Hg despite adequate volume resuscitation and vasopressors)
- •15. Status epilepticus
- •16. Pregnancy
- •17. Clinically significant anemia (hemoglobin <7 g/dL)
- •18. History of blood clotting disorder; exclude if international normalized ratio (INR) >1.5 and/or thrombocytes <50,000/µL
- •19. Moderate to severe renal impairment with estimated glomerular filtration rate <60 mL/min
- •20. Hepatic dysfunction with 1 or more of the following liver function test results: total bilirubin >2 x upper limit of normal (ULN), alanine aminotransferase >2.5 x ULN, or aspartate aminotransferase >2.5 x ULN, INR >1.5
- •21. 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
- •22. 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
- •23. Wearing an opt out bracelet or is known not to wish to participate in this type of study
研究者
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