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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Arm | Placebo Comparator |
| |
| propranolol | Active Comparator | propranolol |
|
| carvedilol | Active Comparator | Carvid (carvedilol) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| control | Drug | Patients will receive standard care with no interventions until end of treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of In-hospital mortality | Difference between the study grous in terms of the percentage of all-cause mortality at the end of treatment | 14 days |
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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:
Exclusion Criteria:
Patients on pre-injury beta-blocker therapy.
Patients with any bronchospastic conditions.
Patients with active acute coronary syndrome.
TBI with GCS ≤ 13 with associated major injuries defined as the presence of any of the following:
Patients with persistent shock (systemic blood pressure <100 mmHg, base deficit > 4, or oliguria , HR < 60 b/min ) after > one week of admission.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aya Osama Nagaty | Contact | 00201097721011 | doctoraya_15@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zagazig University Hospitals, Zagazig, | Recruiting | Zagazig | Egypt | |||
| Zagazig University Hospitals |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D011433 | Propranolol |
| D000077261 | Carvedilol |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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| propranolol | Drug | starting at 20mg propranolol three times daily by mouth or per feeding tube. The dose was increased daily in 20mg three times daily increments (60mg/day total) until heart rate (HR) was less than 100 beats per minute (bpm) with maximum dose of 640mg/day in addition to standard care until end of treatment. |
|
| Carvedilol | Drug | starting at 6.25mg carvedilol three times daily by mouth or per feeding tube. The dose was increased daily in 6.25 mg three times daily increments (18.75 mg/day total) until heart rate (HR) was less than 100 beats per minute (bpm) with maximum dose of 100 mg/day in addition to standard care until end of treatment. |
|
| Not yet recruiting |
| Zagazig |
| Egypt |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |