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| [ ...Back to search results ] | [ Print-friendly version ] |
| The role of early surgery in patients paralysed following injury |
| ISRCTN | ISRCTN61263382 |
| ClinicalTrials.gov identifier | |
| Public title | The role of early surgery in patients paralysed following injury |
| Scientific title | 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 |
| Acronym | 24.72HSCITL |
| Serial number at source | N/A |
| Study hypothesis |
The role and timing of surgical decompression after an acute spinal cord injury (SCI) remains one of the most controversial topics pertaining to spinal surgery. Blunt spinal trauma complicated by injury to the spinal cord most frequently occurs in the young male patient. The lack of controlled, prospective, multicenter clinical studies has contributed to confusion regarding optimal treatment methods for patients with injuries to the spinal cord. The spinal cord is vulnerable to injury resulting from high-energy motor vehicle collisions and falls. Regarding location of spinal cord, cervical and thoracolumbar area can be selected. This RCT tries to evaluate the thoracolumbar cord which we evaluated this area in previous retrospective studies. Thus, we chose patients with acute spinal cord injury from T1 to L1.
Hypothesis: first 24 hours surgical decompression is more effective than 24-72 hours in neurological improvement in the setting of traumatic spinal cord injury from T1 to L1. |
| Lay summary | |
| Ethics approval |
1. Ethics Committee of the Sina Trauma and Surgery Research Centre, Tehran University of Medical Sciences, approved on the 3rd June 2008 (ref: 15)
2. Ethics Committee of the Shahid Beheshti University of Medical Sciences, approved on the 28th October 2007 (ref: 44) |
| Study design | Randomised controlled trial |
| Countries of recruitment | Iran |
| Disease/condition/study domain | Spinal cord injury (SCI) |
| Participants - 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 |
| Participants - 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 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. |
| Anticipated start date | 22/05/2009 |
| Anticipated end date | 21/05/2013 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 328 |
| Interventions | Surgical decompression of compressed spinal cord and stabilisation. This intervention is performed in both groups of early and so called late decompression. Because surgical technique varies according to the location of injury in the spine and the nature of the injury, surgeons are not restricted in their surgical technique. |
| Primary outcome measure(s) | To determine whether early or late surgical decompression is effective in neurological improvement in the setting of traumatic spinal cord injury from T1 to L1, assessed at all clinical assessment timepoints. |
| Secondary outcome measure(s) |
1. To compare the neurological improvement in summed ASIA motor scores 12 months following a complete SCI in each of the early and late group of decompression
2. To compare the neurological improvement in summed ASIA motor scores 12 months following an incomplete SCI in each of the early and late group of decompression 3. To assess the extent of neural canal decompression in each of the early and late group of decompression 4. To assess fusion success in each of the early and late group of decompression 5. To assess sagittal alignment at fracture level in each of the early and late group of decompression 6. To compare the duration of acute hospitalization in each of the early and late group of decompression 7. To compare the overall length of acute hospital stay in each of the early and late decompression 8. To compare the overall length of chronic hospital stay for rehabilitation [22] in each of the early and late decompression 9. To assess the incidence of mortality in each of the early and late group of decompression 10. To determine frequency of complications in each of the early and late group of decompression Timepoints of assessment: 1. First clinical assessment: At the time of admission 2. Second clinical assessment: In the last hour before operation 3. Third clinical assessment: Immediately after operation and awakening from anaesthesia 4. Fourth clinical assessment: Six weeks after operation 5. Fifth clinical assessment: Six months after operation 6. Sixth clinical assessment: 12 months after operation 7. Seventh clinical assessment: The most recent follow-up Imaging check up: First: Before operation Second: Within a maximum of 7 days after operation Third: 12 months after operation Each of the other secondary outcome measures is evaluated at least twice: first before operation and 12 months after operation. |
| Sources of funding |
1. Sina Trauma and Surgery Research Centre, Tehran University of Medical Sciences (Iran) (Grant number: 76) (date confirmed: 3rd June 2008)
2. Shahid Beheshti University of Medical Sciences (Iran) (Grant number: 400/6691) (date confirmed: 18th January 2009) |
| Trial website | |
| Publications | 2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19703282 |
| Contact name | Prof Vafa Rahimi-Movaghar |
| Address |
Research Centre for Neural Repair
Sina Trauma and Surgery Research Centre Sina Hospital Hassan-Abad Square Imam Khomeini Ave Tehran University of Medical Sciences |
| City/town | Tehran |
| Zip/Postcode | 11365-3876 |
| Country | Iran |
| Tel | +98 915 342 2682 |
| Fax | +98 216 670 5140 |
| v_rahimi@sina.tums.ac.ir | |
| Sponsor | Sina Trauma and Surgery Research Centre (Iran) |
| Address |
Sina Hospital
Hassan-Abad Square Imam Khomeini Ave Tehran University of Medical Sciences |
| City/town | Tehran |
| Zip/Postcode | 11365-3876 |
| Country | Iran |
| Tel | +98 216 670 5140 |
| Fax | +98 216 670 5140 |
| sintrc_head@sina.tums.ac.ir | |
| Sponsor website: | http://www.sinatrc.ac.ir/ |
| Date applied | 06/05/2009 |
| Last edited | 03/09/2009 |
| Date ISRCTN assigned | 28/05/2009 |
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| © 2012 ISRCTN unless otherwise stated. | |
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