Effect of Progesterone Administration on Severely Head Injured Patients

Phase 1

Not yet recruiting

• Conditions: Severe Head Trauma
• Interventions: Drug: The usual head trauma care; Drug: Progesterone

• Registration Number: NCT06631547
• Lead Sponsor: Assiut University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-04
• Study First Submitted QC: 2024-10-07
• Last Update Submitted: 2024-10-07
• Study First Posted: 2024-10-08
• Last Update Posted: 2024-10-08
• Study Start: 2025-12-01
• Primary Completion: 2027-01-31
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
patients with main lines of management without progesterone	The usual head trauma care	patients with main lines of management without progesterone
Patients taking progesterone plus the main lines of management of traumatic brain injury	Progesterone	taking progesterone IM 1mg/kg twice for 5 days plus the main lines of management of traumatic brain injury
Patients taking progesterone plus the main lines of management of traumatic brain injury	The usual head trauma care	taking progesterone IM 1mg/kg twice for 5 days plus the main lines of management of traumatic brain injury

Primary Outcome Measures

Name	Time	Method
Glasgow outcome scale GOS-E score	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)
FIM score	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 Outcome Measures

Name	Time	Method
mortality rate	1 month	death rate at 1 month
Duration of hospital stay	1month	Duration of hospital stay
Duration of mechanical ventilator	1month	Duration of mechanical ventilator
adverse events	1 month	adverse events
Gcs	1 year	Gcs