Mgso4 as Neuroprotective in Post Traumatic Brain Injury

NCT04646876 | Completed Phase 3 DMC

• 1 other identifier: N-142-2019
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to assess the potential role of magnesium sulphate (MgSo4) as a neuroprotective agent using the Glasgow outcome scale following moderate and severe traumatic brain injury.

Conditions

Magnesium Sulphate; Traumatic Brain Injury; Brain; Injury

Keywords

Magnesium; Sulphate; double; blinded; randomized; control; study

Outcome Measures

Primary Outcomes (1)

• Glasgow outcome scale after 2 months

  assessment of conscious level of the patients after 60 days of drug administration The Glasgow outcome scale (GOS) has been used to categorize the outcome after 2 months as follows: 1. Death. 2. Persistent vegetative state: Minimal responsiveness. 3. Severe disability: Conscious but disabled; dependent on others for daily support. 4. Moderate disability: Disabled but independent; can work in sheltered setting. 5. Good recovery: Resumption of normal life despite minor deficits. Better score means that the patient conscious level is improved

  60 days from drug administration

Study Arms (2)

intervention arm ( Group A )

ACTIVE COMPARATOR

including 30 patients Group A was given magnesium Sulphate Administration regimen of Mgso4 was as following: Initial dose: within 24 hrs of trauma 50 mg / kg / IV infusion over 1 hour. Maintenance dose: (25 mg / kg) per dose twice daily for 48 hrs.

Drug: Magnesium Sulfate

Placebo arm (Group B )

PLACEBO COMPARATOR

including 30 patients Placebo control study Group B was given saline as a placebo. with the same regimen and route of administration of magnesium sulphate

Drug: Placebo

Interventions

Magnesium Sulfate DRUG

Prospective , comparative , double blind study

Also known as: Mgso4

intervention arm ( Group A )

Placebo DRUG

Prospective , comparative , double blind study

Also known as: Saline

Placebo arm (Group B )

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \) Patients with moderate (GCS = 9-12), or severe (GCS = 3-8) traumatic brain injury.
• \) Age above 12 years.
• \) Consenting for treatment within 24 hours of trauma.

You may not qualify if:

• \) Non consenting patients.
• \) Persistent hypotension (BP below 90 / 60) in 1st 24 hours despite measures of resuscitation.
• \) Significant multisystem association (e.g. cord injury with spinal shock).
• \) Known case of renal failure

Sponsors & Collaborators

• Osama Mohamed Abdelwahab: lead

Study Sites (1)

Faculty of medicine , Cairo university

Cairo, 11511, Egypt

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Wounds and Injuries

Interventions

Magnesium Sulfate; Sodium Chloride

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Sodium Compounds

Study Officials

• Osama Awahab, professor

  Faculty Of Medicine , Beni Suef University , Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The researcher did not know the type of medication given to the patients, placebo or treatment actually Only investigator knew the key
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor Osama Mohamed Abdelwahab

Model Details: 2 groups, comparative

Study Record Dates

• First Submitted: February 22, 2020
• First Posted: November 30, 2020
• Study Start: May 2, 2019
• Primary Completion: March 12, 2020
• Study Completion: June 2, 2020
• Last Updated: November 30, 2020

Record last verified: 2020-11

Locations

EG (1)