Cytoprotective Effect and Clinical Outcome of Perioperative Proesterone in Brain Tumors

NCT ID: NCT04414020

Last Updated: 2020-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2020-09-30

Brief Summary

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Neuronal injury is evident in elective craniotomy for space occupying lesions. Surgical trauma and mechanichal impact of the tumor causes neuronal injury. Neurosreroid progesterone is a neurotransmittern , trail to use in abolishing neurotoxcicty

Detailed Description

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Progesterone is a natural neurosteroid that we are trying to use to impede both direct neuronal injury cauesd by and indirectly by surgical trauma. Progesterone can decreas vasogenic brain oedema. Our primary outcome is to ameliorate microscopic cytoplasmic injury and decrease brain oedema exploited by biopsy from brain tumor interface. Exclusion criteria demonstratd as refusal to participate in the trial , emergency craniotomy, recurrent brain tumor.

Conditions

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Diffuse Traumatic Cerebral Edema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Control

Control group receiving conventional treatment without progesterone

Group Type NO_INTERVENTION

No interventions assigned to this group

progesterone group

1mg pregesterone intramusculer given 7 days pre and post operative , Biopsy was achieved from brain tumor interface

Group Type ACTIVE_COMPARATOR

Progesteron

Intervention Type DRUG

intramusculer progesterone

Interventions

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Progesteron

intramusculer progesterone

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* All elective brain tumors elligible for craniotomy

Exclusion Criteria

* Refusal to participare
* Emergency craniotomy
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Minia University

OTHER

Sponsor Role lead

Responsible Party

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Mina Maher

Principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Medicine

Al Minyā, Abohelal, Egypt

Site Status RECRUITING

Faculty of Medicine

Minya, Abohelal, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mina Raouf, MD

Role: CONTACT

01015752424

Facility Contacts

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mina raouf, MD

Role: primary

01015752424

omaima mohammad, MD

Role: backup

01061762894

mina raouf, MD

Role: primary

01015752424

omaima mohammad, MD

Role: backup

01061762894

Other Identifiers

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623-4/2020

Identifier Type: -

Identifier Source: org_study_id

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