Effect of Progesterone Administration on Severely Head Injured Patients

Phase 1Not Yet RecruitingNCT06631547

Assiut University50 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Severe Head Trauma

Interventions

ProgesteroneDRUG

Hormonal treatment

The usual head trauma careDRUG

the basic treatment

Eligibility

Sex: ALLMin age: 16 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Glasgow outcome scale GOS-E score

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)

Time frame: 1year

FIM score

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

Time frame: 1 year

Secondary Outcomes

mortality rate

death rate at 1 month

Time frame: 1 month

Duration of hospital stay

Time frame: 1month

Duration of mechanical ventilator

Time frame: 1month

adverse events

Time frame: 1 month

Gcs

Time frame: 1 year

Central Contacts

Islam Abd El Aal Helmy

CONTACT

+20 1068825066 islamabdelal3@gmail.com

Data from ClinicalTrials.gov

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