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

Sponsor
Minia University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04426487
Collaborator
(none)
200
Enrollment
1
Location
2
Arms
4.3
Anticipated Duration (Months)
46.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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 .

Condition or Disease Intervention/Treatment Phase
Early Phase 1

Detailed 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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Care Provider)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Jun 20, 2020
Anticipated Primary Completion Date :
Sep 1, 2020
Anticipated Study Completion Date :
Oct 30, 2020

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Control

Receiving conventional management for traumatic subarachinoid hemorrhage

Drug: Progesterone
Intramusculer progesterone
Active Comparator: progesterone group

Intramusculer progesterone therapy before and after craniotomy

Drug: Progesterone
Intramusculer progesterone

Outcome Measures

Primary Outcome Measures

  1. Number of participants suffering neuronal infarction [2 months]

    Transcranial doppler

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Traumatic subarachinoid hemorrhage
Exclusion Criteria:

  • History of malignency

  • History of cerebrovasculer stroke

  • Morbid obese

Contacts and Locations

Locations

Site City State Country Postal Code
1 ElMinia University Minya Abohelal Egypt 6115

Sponsors and Collaborators

  • Minia University

Investigators

  • Study Director: Hany Mikhail, MD, Faculty of medicine. ElMinia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mina Maher, Principle investigator, Ministry of Health and Population, Egypt
ClinicalTrials.gov Identifier:
NCT04426487
Other Study ID Numbers:
  • 625/4-2020
First Posted:
Jun 11, 2020
Last Update Posted:
Jun 11, 2020
Last Verified:
Jun 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by Mina Maher, Principle investigator, Ministry of Health and Population, Egypt
Progesterone
Transcranial doppler
Additional relevant MeSH terms:
Brain Injuries
Brain Injuries, Traumatic
Hemorrhage
Progesterone

Study Results

No Results Posted as of Jun 11, 2020