Condition category
Injury, Occupational Diseases, Poisoning
Date applied
06/05/2009
Date assigned
28/05/2009
Last edited
03/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Vafa Rahimi-Movaghar

ORCID ID

Contact details

Research Centre for Neural Repair
Sina Trauma and Surgery Research Centre
Sina Hospital
Hassan-Abad Square
Imam Khomeini Ave
Tehran University of Medical Sciences
Tehran
11365-3876
Iran
+98 915 342 2682
v_rahimi@sina.tums.ac.ir

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

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.

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Spinal cord injury (SCI)

Intervention

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.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 measures

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.

Overall trial start date

22/05/2009

Overall trial end date

21/05/2013

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

328

Participant 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.

Recruitment start date

22/05/2009

Recruitment end date

21/05/2013

Locations

Countries of recruitment

Iran

Trial participating centre

Research Centre for Neural Repair
Tehran
11365-3876
Iran

Sponsor information

Organisation

Sina Trauma and Surgery Research Centre (Iran)

Sponsor details

Sina Hospital
Hassan-Abad Square
Imam Khomeini Ave
Tehran University of Medical Sciences
Tehran
11365-3876
Iran
+98 216 670 5140
sintrc_head@sina.tums.ac.ir

Sponsor type

University/education

Website

http://www.sinatrc.ac.ir/

Funders

Funder type

University/education

Funder name

Sina Trauma and Surgery Research Centre, Tehran University of Medical Sciences (Iran) (Grant number: 76) (date confirmed: 3rd June 2008)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Shahid Beheshti University of Medical Sciences (Iran) (Grant number: 400/6691) (date confirmed: 18th January 2009)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19703282

Publication citations

  1. Protocol

    Rahimi-Movaghar V, Saadat S, Vaccaro AR, Ghodsi SM, Samadian M, Sheykhmozaffari A, Safdari SM, Keshmirian B, 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 randomized controlled trial., Trials, 2009, 10, 77, doi: 10.1186/1745-6215-10-77.

Additional files

Editorial Notes