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NCT04426487 Clinical Trial

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

Traumatic Brain Injury Clinical Trial

Official title:
Effect of Progesterone Therapy in Cases With Traumatic Subarachinoid Haemorrhage on Clinical Outcome and Resistive Vasculer Indices of Middle Cerebral Artery Transcranial Doppler

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04426487
Other study ID # 625/4-2020
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date June 20, 2020
Est. completion date October 30, 2020

Study information
Verified date June 2020
Source Minia University
Contact Mina Raouf, MD
Phone 01015752424
Email drmina2015@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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 .

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

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date October 30, 2020
Est. primary completion date September 1, 2020
Accepts healthy volunteers No
Gender All
Age group 20 Years to 65 Years
Eligibility Inclusion Criteria:

- Traumatic subarachinoid hemorrhage

Exclusion Criteria:

- History of malignency

- History of cerebrovasculer stroke

- Morbid obese

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Progesterone
Intramusculer progesterone

Locations
Country Name City State
Egypt ElMinia University Minya Abohelal

Sponsors (1)
Lead Sponsor Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants suffering neuronal infarction Transcranial doppler 2 months
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