Beta Blocker Effects in Traumatic Brain Injury
Beta Blocker Effects on Patients With Traumatic Brain Injury
1 other identifier
interventional
40
1 country
1
Brief Summary
The study will be conducted on polytrauma patient who are admitted from emergency room or postoperative with head trauma to evaluate effects of beta blocker on patients with TBI.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Oct 2021
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2021
CompletedFirst Submitted
Initial submission to the registry
December 2, 2021
CompletedFirst Posted
Study publicly available on registry
January 19, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2022
CompletedMarch 17, 2023
March 1, 2023
6 months
December 2, 2021
March 16, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
survival
number of surviving in patients receiving propranolol and patients who did not receive any beta blocker
7 days
Secondary Outcomes (2)
heart rate
7 days
icu stay
7 days
Study Arms (2)
beta blocker
ACTIVE COMPARATORWill be given Propranolol 1mg in 10 ml distilled water intravenous every 6 hours for 48 hours
placebo
PLACEBO COMPARATORWill be given normal saline 10 ml every 6 hours for 48 hours
Interventions
Eligibility Criteria
You may qualify if:
- GCS preoperative \>10
- Abbreviated Injury Scale (AIS) \>3
- Length stay in ICU \>48 h
You may not qualify if:
- Hypersensitivity to propranolol
- Asthmatic patient
- COPD
- History of smoking
- Any cardiac problems eg: ( heart failure or HB )
- pheochromocytoma
- Pregnant patient
- Length stay \<48h
- Death within 48 h of admission
- Patient who previously received any beta blocker at home.
- Symptomatic Bradycardia \<60 b/m (sick sinus syndrome)
- Hemodynamic unstable patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Medicine, University Hospitals
Shibīn al Kawm, Menoufia, 32511, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
mostafa f mansour, MD
Menoufia University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- lecturer
Study Record Dates
First Submitted
December 2, 2021
First Posted
January 19, 2022
Study Start
October 1, 2021
Primary Completion
March 31, 2022
Study Completion
May 31, 2022
Last Updated
March 17, 2023
Record last verified: 2023-03