Effect of Progesterone Therapy on Traumatic Subarachinoid Haemorrhage on Clinical Outcome and Resistive Vasculer Indices of Middle Cerebral Artery Transcranial Doppler

Minia University

Status and phase: Unknown; Early Phase 1

Conditions: Traumatic Brain Injury

Treatments: Drug: Progesterone

Study type: Interventional

Funder types: Other

Identifiers

NCT04426487

625/4-2020

Details and patient eligibility

About

Traumatic subarachinoid hemorrhage is associated with serious complications related to mortality . Delayed neuronal ischemia and rebleeding are most common and serious. Progesterone can delay both .

Full description

Progesterone is an neurosteroid that can help integrity of blood brain barrier . Traumatic subarachinoid hemorrhage disrupts this blood brain barrier facilitating post traumatic vasospasm and neuronal ischemia. Transcranial doppler can detect cerebral vasoconstriction through resistive vasculer indices

Enrollment: 200 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Traumatic subarachinoid hemorrhage

Exclusion criteria

• History of malignency

  • History of cerebrovasculer stroke
  • Morbid obese

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

Receiving conventional management for traumatic subarachinoid hemorrhage

Treatment:

Drug: Progesterone

progesterone group

Active Comparator group

Description:

Intramusculer progesterone therapy before and after craniotomy

Treatment:

Drug: Progesterone