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 @ 10:58 PM
Ignite Modification Date:
2025-12-24 @ 10:58 PM
NCT ID:
NCT00375869
Eligibility Criteria:
Inclusion Criteria:
* Age 18-70 inclusive.
* Admitted to ICU with a TBI and a GCS ≤ 8 with a motor score \< 6.
* Patient must have a functioning external ventricular drain in place for intracranial pressure (ICP) monitoring.
* Completion of informed consent by the next-of-kin or legal guardian.
* Randomization within 12 hours of initial triage by medical or paramedical staff.
* Abnormal CT of the brain.
Exclusion Criteria:
* Pregnancy
* Cardiac arrest during the current hospital admission.
* Bilateral non-reactive dilated pupils at the time of randomization.
* A history of renal failure, NYHA class IV congestive heart failure, or recent myocardial infarction (within 6 months).
* A history of primary or secondary polycythemia.
* Previous adverse reactions to rhEPO or darbepoetin.
* Previous history of seizure disorder.
* Recent history (within the past 3 months) of significant uncontrolled hypertension defined as SBP \> 200 mm Hg or DBP \> 110 mmHg.
* Patients involved in other clinical investigations involving therapeutic interventions
* Hemoglobin ≥150 g/L in females
* Hemoglobin ≥160g/L in males
* Past history of thrombotic events
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00375869
Study Brief:
Protocol Section:
NCT00375869