DELAYED VERSUS EARLY SURGICAL DECOMPRESSION FOR TRAUMATIC SPINAL CORD INJURY
ConditionTraumatic Spinal Cord Injury
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorFauji Foundation Hospital
About this trial
To compare the outcome of early versus delayed surgical decompression among patients presenting with traumatic spinal cord injury in a tertiary care hospital.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients presenting with spinal cord injury (both cervical and thoracic) as per described in the operational definition
Age from 18-60 years
Both male and female patients
Disqualifiers
Patients with penetrating spinal injuries such as gunshot/stab wounds
Patients with pre-existing neurological conditions like myelopathy etc.
Patients with any kind of malignancy
Patients having CSF infection etc.
Trial population
• Patients presenting with spinal cord injury (both cervical and thoracic)
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Early Surgical Decompression
Procedure/Surgeryit will be defined as the surgical decompression performed within 24 hours of injury. It will be performed among all the patients who presented within 24 hours of injury.
Delayed Surgical Decompression
Procedure/SurgeryIt will be defined as the surgical decompression performed after 24 hours of spinal cord injury. It will be performed among all the patients who needed it due to medical optimization (such as hemodynamically unstable, shock, pulmonary contusions, cerebrovascular destabilization etc.) or those who will present after 24 hours of injury due to logistical delay.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
improvement in neurological impairment using ASIA Impairment Scale (AIS)
Treatment outcomes will be measured 12 weeks after early or delayed surgical decompression among all the patients who underwent spinal cord injury in terms of improvement in neurological impairment using ASIA Impairment Scale (AIS) attached as annexure-C. Outcome will be labelled as good if shows improvement for at least two AIS grades.
Time frame
12 Weeks after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov