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NCT Number: NCT06631547

Effect of Progesterone Administration on Severely Head Injured Patients

To investigate the effectiveness of progesterone as a neuroprotective in patients severe traumatic brain injury in clinical outcome

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Key information

Conditions

Severe Head Trauma Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

16 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

patients with severe traumatic head injury GCS ≤8 both sexes.

>16yrs,

-

Exclusion criteria

  • -Tumor that may flare with progesterone.
  • patients with spinal injuries with neurological deficits.
  • severe chest trauma that causes shock and hypoxia.
  • life-threatening systemic injuries that cause hemodynamic instability, cardiac arrest
  • pegnancy

Treatment and study plan

Progesterone

Drug

Hormonal treatment

The usual head trauma care

Drug

the basic treatment

Primary outcomes

  1. Glasgow outcome scale GOS-E score

    Time frame: 1year

    as thhe following:1-indicates death 2-indicates a vegetative state, 3 or 4 indicates a severe disability, 5 or 6 indicates a moderate disability and 7 or 8 indicates a good recovery. (8, 9)

  2. FIM score

    Time frame: 1 year

    is available measure of dependence in two subscales (motor and cognitive) (10) . Motor domains self care (eating, grooming, bathing, body upper dressing, body lower dressing, swallowing, moving to bed and chair, toileting

Secondary outcomes

  1. mortality rate

    Time frame: 1 month

    death rate at 1 month

  2. Duration of hospital stay

    Time frame: 1month

    Duration of hospital stay

  3. Duration of mechanical ventilator

    Time frame: 1month

    Duration of mechanical ventilator

  4. adverse events

    Time frame: 1 month

    adverse events

  5. Gcs

    Time frame: 1 year

    Gcs

Study contacts

Contact information is provided by the study sponsor or research team.

Islam Abd El Aal Helmy

CONTACT

[email protected]

+20 1068825066

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Effect of Progesterone Administration on Severely Head Injured Patients: Hospital Based Study

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 8, 2024
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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