NCT05551871

Brief Summary

Traumatic brain injury (TBI) is a common cause of long-term neurological morbidity, with devastating personal and societal consequences. At present, no pharmacological intervention clearly improves outcomes, and therefore a compelling unmet clinical need remains. 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors, or "statins," offer a potential novel therapeutic strategy for TBI. In this study the investigators will study primarily the effect of statins on 30-day mortality rate which is defined as death within 30 days of TBI presentation where the occurrence of TBI is hour 0 or day 0 and secondarily evaluation of duration of ICU stay associated with or without complications.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 23, 2022

Completed
8 days until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

October 10, 2022

Status Verified

October 1, 2022

Enrollment Period

1.2 years

First QC Date

September 20, 2022

Last Update Submit

October 6, 2022

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

  • 30-day mortality rate

    defined as death within30 days of TBI presentation where the occurrence of TBI is hour 0 or day 0.

    30 days

Secondary Outcomes (5)

  • 1. ICU stay

    30 days

  • Complications

    30 days

  • Glasgow Coma Scale (GCS)

    30 days

  • CBC

    30 days

  • CRP

    30 days

Study Arms (2)

Simvastatin

ACTIVE COMPARATOR

the patient will receive simvastatin 40mg

Drug: Simvastatin

Placebo

PLACEBO COMPARATOR

the patient will receive placebo drug

Drug: Placebo drug

Interventions

SimvastatinDRUG

the patient will receive Simvastatin for 7 days

Simvastatin
Placebo drugDRUG

the patient will receive Placebo drug for 7 days

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • adult patients from 18 to 40 years old with mild to moderate TBI

You may not qualify if:

  • immunotherapy
  • diabetic
  • previous CNs dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Menon DK, Schwab K, Wright DW, Maas AI; Demographics and Clinical Assessment Working Group of the International and Interagency Initiative toward Common Data Elements for Research on Traumatic Brain Injury and Psychological Health. Position statement: definition of traumatic brain injury. Arch Phys Med Rehabil. 2010 Nov;91(11):1637-40. doi: 10.1016/j.apmr.2010.05.017.

    PMID: 21044706BACKGROUND

  • Barlow KM. Traumatic brain injury. Handb Clin Neurol. 2013;112:891-904. doi: 10.1016/B978-0-444-52910-7.00011-8.

    PMID: 23622299BACKGROUND

  • Iaccarino C, Carretta A, Nicolosi F, Morselli C. Epidemiology of severe traumatic brain injury. J Neurosurg Sci. 2018 Oct;62(5):535-541. doi: 10.23736/S0390-5616.18.04532-0.

    PMID: 30182649BACKGROUND

  • Peng W, Yang J, Yang B, Wang L, Xiong XG, Liang Q. Impact of statins on cognitive deficits in adult male rodents after traumatic brain injury: a systematic review. Biomed Res Int. 2014;2014:261409. doi: 10.1155/2014/261409. Epub 2014 Jul 23.

    PMID: 25157352BACKGROUND

  • Wible EF, Laskowitz DT. Statins in traumatic brain injury. Neurotherapeutics. 2010 Jan;7(1):62-73. doi: 10.1016/j.nurt.2009.11.003.

    PMID: 20129498BACKGROUND

  • Kumar A, Loane DJ. Neuroinflammation after traumatic brain injury: opportunities for therapeutic intervention. Brain Behav Immun. 2012 Nov;26(8):1191-201. doi: 10.1016/j.bbi.2012.06.008. Epub 2012 Jun 21.

    PMID: 22728326BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Emad Zarief Kamel, MD

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Muhammad Hamdi Taha Muhammad

CONTACT

+201020410196muhammadhamdi181@gmail.com

Emad Zarief Kamel, MD

CONTACT

+201007046058emadzarief@aun.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator , anesthesiology and ICU resident

Study Record Dates

First Submitted

September 20, 2022

First Posted

September 23, 2022

Study Start

October 1, 2022

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

October 10, 2022

Record last verified: 2022-10