Effect of Progesterone Administration on Severely Head Injured Patients

Assiut University

Status and phase: Not yet enrolling; Phase 1

Conditions: Severe Head Trauma

Treatments: Drug: Progesterone; Drug: The usual head trauma care

Study type: Interventional

Funder types: Other

Identifiers

NCT06631547

Pgs in head trauma

Details and patient eligibility

About

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

Enrollment: 50 estimated patients

Sex: All

Ages: 16 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups, including a placebo group

patients with main lines of management without progesterone

Placebo Comparator group

Description:

patients with main lines of management without progesterone

Treatment:

Drug: The usual head trauma care

Patients taking progesterone plus the main lines of management of traumatic brain injury

Active Comparator group

Description:

taking progesterone IM 1mg/kg twice for 5 days plus the main lines of management of traumatic brain injury

Treatment:

Drug: The usual head trauma care

Drug: Progesterone