ISRCTN61263382
Completed
未知
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 sites73 target enrollmentMay 28, 2009
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Sina Trauma and Surgery Research Centre (Iran)
- Enrollment
- 73
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
2009 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/19703282 protocol 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/34223533/ (added 28/10/2022)
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Both males and females, 18 years or older
- •2\. Spinal cord injury between T1 and L1 of traumatic etiology
- •3\. Haemodynamically stable
- •4\. Spinal cord compression on magnetic resonance imaging (MRI)
- •5\. Between 0 hours and 24 hours post\-injury
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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