The efficacy of surgical decompression before 24 hours versus 24 to 72 hours in patients with spinal cord injury from T1 to L1 - with specific consideration on ethics: a randomised controlled trial

Sina Trauma and Surgery Research Centre (Iran)0 个研究点目标入组 73 人开始时间: 2009年5月28日最近更新: 2022年11月7日

试验速览

•1. Subjects with major and current psychiatric illness
•2. Significant traumatic brain injury associated with the spinal cord injury
•3. Major concurrent medical disease (including myocardial infarction within 3 months, uncompensated congestive heart failure, active systemic cancer, acquired immune deficiency syndrome [AIDS], diabetes mellitus)
•4. Pre-injury major neurologic deficits or disease (e.g., stroke, Parkinson's disease, syringomyelia, Guilian-Barre)
•5. Ankylosing spondylitis
•6. Penetrating injuries to the thoracolumbar
•7. Pregnant females
•8. Life-threatening injuries which prevent early decompression of the spinal cord
•9. Criminals
•10. Under indictment or incarceration
•11. Substance abuse
•12. American Spinal Injury Association (ASIA) Impairment Scale category of E
•13. No cord compression on MRI
•14. Presence of spinal shock
•15. Any cognitive deficit
•16. Unable to provide informed consent
•17. An injury which involves more than two adjacent vertebral levels
•Selected participants are thoroughly informed of the trial and its attendant risks and asked to consent to be in one of two groups, those operated urgently in less than 24 hours from trauma or the late group who are operated and decompressed between 24 and 72 hours from trauma.

发起方

Sina Trauma and Surgery Research Centre (Iran)