NCT06836856 Evaluating the Impact of Adjuvant Use of Beta Blockers on Clinical Outcomes in Patients With Traumatic Brain Injury
| NCT ID | NCT06836856 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Mansoura University |
| Condition | TBI Traumatic Brain Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-01-20 |
| Primary Completion | 2025-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 100 participants in total. It began in 2025-01-20 with a primary completion date of 2025-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Propranolol primarily acts as a non-selective beta blocker, blocking both beta-1 and beta-2 adrenergic receptors, while carvedilol exhibits a broader spectrum of action by also blocking alpha-1 adrenergic receptors. The receptor blockade profile of a beta blocker can influence its physiological effects and potential therapeutic benefits in TBI. Therefore, the variation in receptor selectivity may result in differences in their impact on secondary brain injury processes and patient outcomes.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06836856 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying TBI Traumatic Brain Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06836856 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06836856 currently recruiting?
Yes, NCT06836856 is actively recruiting participants. Contact the research team at doctoraya_15@yahoo.com for enrollment information.
Where is the NCT06836856 trial being conducted?
This trial is being conducted at Zagazig, Egypt, Zagazig, Egypt.
Who is sponsoring the NCT06836856 clinical trial?
NCT06836856 is sponsored by Mansoura University. The trial plans to enroll 100 participants.