To assess the safety and efficacy of using oral Glyburide (Diabeta) as a neuroprotective agent in patients with acute cervical or thoracic traumatic spinal cord injury.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* No life threatening injuries resulting from the traumatic accident
* No evidence of sepsis
* Acute cervical or thoracic SCI with ASIA Impairment Scale Grade A, B, or C od admission.
* Non-penetrating SCI at neurologic level from C2 to C8 or T1 to T12
Exclusion Criteria:
* Unconsciousness or other mental impairment that prevents neurological assessment within the first 8 hours
* Acute SCI with ASIA Impairment Scale grade D or E
* Currently involved in another non-observational SCI research study or receiving another investigational drug
* History of hypersensitivity to sulfonylureas, in particular glyburide, or any of its components
* Any condition likely to result in the patient's death within the next 12 months
* Severe renal disorder from the patient's history (e.g. dialysis) or baseline eGFR of \< 30 mL/min/1.73 m2
* Known severe liver disease, or ALT \> 3 times upper limit of normal or bilirubin
* Blood glucose \<55 mg/dL at enrollment or immediately prior to administration of DiaBeta, or a clinically significant history of hypoglycemia
* Acute ST elevation myocardial infarction, and/or acute decompensated heart failure, and/or QTc \> 520 ms, and/or known history of cardiac arrest (PEA, VT, VF, asystole), and/or admission for an acute coronary syndrome, myocardial infarction, or coronary intervention (percutaneous coronary intervention or coronary artery surgery) within the past 3 months
* Known G6PD enzyme deficiency
What they're measuring
1
Rate of recruitment of patients with tSCI within the specified time window.