Beta Blocker Effects in Traumatic Brain Injury | NCT05195996

Studies
Beta Blocker Effects in Traumatic Brain Injury

NCT05195996

Sponsor

Menoufia University

Status

Completed

Last Update Posted

Mar 17, 2023Actual

Enrollment

40Actual

Phase

Phase 4

Conditions

Trauma, Brain

Interventions

Propranolol
Saline

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2021Actual

Primary Completion Date

Mar 31, 2022Actual

Completion Date

May 31, 2022Actual

First Submitted Date

Dec 2, 2021

First Submission Date that Met QC Criteria

Jan 4, 2022

First Posted Date

Jan 19, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 16, 2023

Last Update Posted Date

Mar 17, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

The study will be conducted on polytrauma patient who are admitted from emergency room or postoperative with head trauma . Patients will be randomly assigned into two groups by sealed envelope technique into two equal groups.

Parameters assessment:

Length of ICU stay
Length of total hospital stay
CT scan to exclude another intracranial hemorrhage or increase in hemorrhage
Functional status will be assessed using the GCS
Hemodynamic data ( bl.p / hr )
Crystalloid volume that patient need in 24h
Mortality rate

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
beta blocker	Active Comparator	Will be given Propranolol 1mg in 10 ml distilled water intravenous every 6 hours for 48 hours	Drug: Propranolol
placebo	Placebo Comparator	Will be given normal saline 10 ml every 6 hours for 48 hours	Drug: Saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Propranolol	Drug	intravenous propranolol for case patients	beta blocker

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
survival	number of surviving in patients receiving propranolol and patients who did not receive any beta blocker	7 days

Secondary Outcomes

Measure	Description	Time Frame
heart rate	number of patient showing effect of beta blocker on TBI related to HR	7 days
icu stay	number of patients were beta blocker in TBI affected on ICU and total hospital stay

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

GCS preoperative >10
Abbreviated Injury Scale (AIS) >3
Length stay in ICU >48 h

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

50 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
mostafa f mansour, MD	Menoufia University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine, University Hospitals		Shibīn al Kawm	Menoufia	32511	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000070642	Brain Injuries, Traumatic

Ancestor Terms

ID	Term
D001930	Brain Injuries
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011433	Propranolol
D012965	Sodium Chloride

Ancestor Terms

ID	Term
D050198	Phenoxypropanolamines
D011412	Propanolamines
D000605	Amino Alcohols
D000438	Alcohols

Browse Leaves

Not provided

Browse Branches

Not provided