Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2025-12-24 @ 7:02 PM
NCT ID:
NCT01605357
Eligibility Criteria:
Inclusion Criteria:
* Adults (18 - 60 years old)
* Severe traumatic brain injury with intracranial pressure monitoring
* Initial GCS 5-8 (obtained free of the effects of neuromuscular blockade or sedatives)
* Clearly defined time of injury no more than 8 hours before administration of study drug
* Written consent obtained from legally authorized representative (LAR)
* Severe swelling prone injury patterns:
1. Contusion - frontal or temporal (\> 20 cc)
2. Acute convexity subdural hematoma with any evidence of midline shift
Exclusion Criteria:
* Patients undergoing emergent (within 15 minutes) or urgent neurosurgery (within 4 hours) following emergency department arrival (bedside procedures, such as intracranial pressure monitor placement are excluded)
* Posterior fossa lesions
* Penetrating brain injury
* Spinal column instability and/or spinal cord injury with neurological deficit
* Pregnant
* Concomitant severe nonsurvivable injury
* Acute renal failure ; Chronic renal failure (serum creatinine of \> 2.5 mg/dL, history of ongoing dialysis, glomerular filtration rate \<30mL/min/1.73 m2); Severe pulmonary edema; Severe heart failure; Severe liver failure (AST, ALT, or bilirubin \> 2 times normal)
* Known use of warfarin, clopidogrel, prasugrel, cilostazol, heparin, low molecular weight heparin, heparinoids, abciximab or similar antiplatelet agents
* Treatment with another investigational drug within the prior 30 days
* Systolic blood pressure \< 90 mm HG not responsive to fluid resuscitation
* INR \> 1.4
* Hospitalization for brain injury or neurological disease within previous 3 years
* Admission serum sodium \< 135 mmol/L
* \> 8 hours from the time of injury to admission
* Fix/dilated pupil suspected to be secondary to brainstem compression
* Duret (brainstem) hemorrhage indicating brainstem herniation
* PaO2 \< 60 mmHg on admission (when blood gases are drawn as standard of care)
* Prisoner or other persons unable to make a true, voluntary and uncoerced decision whether or not to participate in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01605357
Study Brief:
Protocol Section:
NCT01605357