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Clinical Trials/ISRCTN61263382
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)

Registry
who.int
Start Date
May 28, 2009
End Date
May 21, 2013
Last Updated
3 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Sina Trauma and Surgery Research Centre (Iran)

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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