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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

Primary Purpose

Traumatic Brain Injury

Status
Unknown status
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Progesterone
Sponsored by
Minia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring Progesterone, Transcranial doppler

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Traumatic subarachinoid hemorrhage

Exclusion Criteria:

  • History of malignency

    • History of cerebrovasculer stroke
    • Morbid obese

Sites / Locations

  • ElMinia UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Control

progesterone group

Arm Description

Receiving conventional management for traumatic subarachinoid hemorrhage

Intramusculer progesterone therapy before and after craniotomy

Outcomes

Primary Outcome Measures

Number of participants suffering neuronal infarction
Transcranial doppler

Secondary Outcome Measures

Full Information

First Posted
June 8, 2020
Last Updated
June 8, 2020
Sponsor
Minia University
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1. Study Identification

Unique Protocol Identification Number
NCT04426487
Brief Title
Effect of Progesterone Therapy on Traumatic Subarachinoid Haemorrhage on Clinical Outcome and Resistive Vasculer Indices of Middle Cerebral Artery Transcranial Doppler
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 20, 2020 (Anticipated)
Primary Completion Date
September 1, 2020 (Anticipated)
Study Completion Date
October 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University

4. Oversight

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
Data Monitoring Committee
No

5. 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 .
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
Progesterone, Transcranial doppler

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Receiving conventional management for traumatic subarachinoid hemorrhage
Arm Title
progesterone group
Arm Type
Active Comparator
Arm Description
Intramusculer progesterone therapy before and after craniotomy
Intervention Type
Drug
Intervention Name(s)
Progesterone
Intervention Description
Intramusculer progesterone
Primary Outcome Measure Information:
Title
Number of participants suffering neuronal infarction
Description
Transcranial doppler
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Traumatic subarachinoid hemorrhage Exclusion Criteria: History of malignency History of cerebrovasculer stroke Morbid obese
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mina Raouf, MD
Phone
01015752424
Email
drmina2015@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hany Mikhail, MD
Organizational Affiliation
Faculty of medicine. ElMinia University
Official's Role
Study Director
Facility Information:
Facility Name
ElMinia University
City
Minya
State/Province
Abohelal
ZIP/Postal Code
6115
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hany Mikhail
Phone
01223448665
Email
hanykm@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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