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 @ 3:01 PM
Ignite Modification Date:
2025-12-24 @ 3:01 PM
NCT ID:
NCT00974259
Eligibility Criteria:
Inclusion Criteria:
1. Non-penetrating traumatic brain injury
2. Requirement for intracranial pressure monitoring according to Guidelines for the Management of Severe TBI, as operationalized below:
* GCS 3-8 (measured off sedatives or paralytics) with abnormal CT scan. If patient is intubated, motor GCS \< 4 required.
* If CT scan normal, motor GCS \< 4 (measured off sedatives or paralytics)
* Intoxication is not a reason for deferring ICP monitoring if above criteria are met.
* If the patient has a witnessed seizure, wait 30 minutes to evaluate GCS.
3. Randomization and placement of monitors within 12 hours of injury.
4. Males and females Age 18-70 years, English or Spanish speaking patients.
Exclusion Criteria:
1. Specific clinical contraindications:
* GCS motor score \> 4 with normal CT scan
* Bilaterally absent pupillary responses
2. Laboratory contraindications per safety considerations:
Coagulopathy that makes insertion of parenchymal monitors contraindicated (Platelets \< 50,000/mL, INR \> 1.4) (Enrollment allowed if coagulopathy can be corrected before 12 hour post-injury deadline).
3. Pregnant females will be excluded. Blood test for pregnancy is a routine part of care in ED's. However, if not done, a urine or blood test will be done as a safety precaution after consent but prior to study treatment.
4. Monitoring with pBrO2 monitor prior to randomization.
5. Clinical, demographic and other characteristics that precludes appropriate diagnosis, treatment or follow-up in the trial.
* Systemic sepsis at the time of screening
* Refractory hypotension (SBP \< 70 mm Hg for \> 30 minutes)
* Refractory systemic hypoxia (paO2 \< 60 mm Hg on FiO2 \< 0.5)
* Evidence of premorbid disabling conditions that interfere with outcome assessment. These include diagnosis of Alzheimer's disease, Parkinson's disease, multiple sclerosis, spinal cord injury with deficits, history of stroke, brain tumors, chronic use of medication for disabling neurologic or psychiatric disorder, or history of suicide attempt within the past year.
* Imminent death or current life-threatening disease
* Prisoner
* Individuals who hold religious beliefs against blood transfusion
* Previous TBI hospitalization greater than 1 day
* Patients who are unlikely to be available for follow-up interview, even by telephone. for example, patients who are homeless, illegal aliens, or live in foreign countries and those with whom future personal (including family) or telephone contact is unlikely.
6. Active drug or alcohol use or dependence that, in the opinion of the stie investigator, would interfere with follow-up.
7. Imminent death or current life-threatening disease
8. Inability or unwillingness of subject or legal guardian/representative to give written informed consent
9. Participation in other observational or interventional clinical trials is allowed as long as the PI of each study agree ahead of time to allow co-enrollment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00974259
Study Brief:
Protocol Section:
NCT00974259