NCT04426487

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 .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jun 2020

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
9 days until next milestone

Study Start

First participant enrolled

June 20, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2020

Completed
Last Updated

June 11, 2020

Status Verified

June 1, 2020

Enrollment Period

2 months

First QC Date

June 8, 2020

Last Update Submit

June 8, 2020

Conditions

Traumatic Brain Injury

Keywords

ProgesteroneTranscranial doppler

Outcome Measures

Primary Outcomes (1)

  • Number of participants suffering neuronal infarction

    Transcranial doppler

    2 months

Study Arms (2)

Control

PLACEBO COMPARATOR

Receiving conventional management for traumatic subarachinoid hemorrhage

Drug: Progesterone

progesterone group

ACTIVE COMPARATOR

Intramusculer progesterone therapy before and after craniotomy

Drug: Progesterone

Interventions

ProgesteroneDRUG

Intramusculer progesterone

Controlprogesterone group

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Traumatic subarachinoid hemorrhage

You may not qualify if:

  • History of malignency
  • History of cerebrovasculer stroke
  • Morbid obese

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ElMinia University

Minya, Abohelal, 6115, Egypt

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Progesterone

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsCorpus Luteum HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsProgesterone CongenersGonadal Steroid Hormones

Study Officials

  • Hany Mikhail, MD

    Faculty of medicine. ElMinia University

    STUDY DIRECTOR

Central Study Contacts

Mina Raouf, MD

CONTACT

01015752424drmina2015@gmail.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

June 8, 2020

First Posted

June 11, 2020

Study Start

June 20, 2020

Primary Completion

September 1, 2020

Study Completion

October 30, 2020

Last Updated

June 11, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)