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 @ 11:24 PM
Ignite Modification Date:
2025-12-24 @ 11:24 PM
NCT ID:
NCT06836856
Eligibility Criteria:
Inclusion Criteria:
1\. Patients with moderate \& severe TBI detected on admission by CT scan and GCS score of ≤ 13 who either do not have any other injuries or only have associated minor injuries.
Minor injuries are defined as presence of any of the following:
1. Mild intraperitoneal free fluid (IPFF) observed through abdominal ultrasound.
2. mild lung contusion detected in the chest CT scan.
3. hemothorax or pneumothorax present without accompanying symptoms of hypoxia, tachypnea, or respiratory distress.
4. simple limb fractures.
Exclusion Criteria:
1. Patients on pre-injury beta-blocker therapy.
2. Patients with any bronchospastic conditions.
3. Patients with active acute coronary syndrome.
4. TBI with GCS ≤ 13 with associated major injuries defined as the presence of any of the following:
1. Moderate \& marked IPFF requiring surgical intervention ( laparotomy ).
2. moderate \& marked lung contusion, pneumothorax \& hemothorax with accompanying symptoms of hypoxia, tachypnea, lower limbs, or limb amputation.
3. Compound fracture in the upper or lower limb.
4. Open Faciomaxillary trauma.
5. Patients with persistent shock (systemic blood pressure \<100 mmHg, base deficit \> 4, or oliguria , HR \< 60 b/min ) after \> one week of admission.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06836856
Study Brief:
Protocol Section:
NCT06836856