Prognostic Factors for Surgical Management of Large Hypertensive Basal Ganglionic Haemorrhage

March 7, 2024 updated by: Ahmed Sameeh, Assiut University
The aim of this study is to present current and comprehensive recommendations for surgical treatment of this hematoma and to determine the factors that may improve the survival rate

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Spontaneous intracerebral hemorrhage is a common, mostly deadly stroke subtype and accounts for 10% to 15% of all strokes.

It's associated with a higher mortality rate (44% after 30 days) than either ischemic stroke or subarachnoid hemorrhage Up to 75% of the long term survivors are often suffering significant disability and only 12% to 39% of the survivors have favourable neurological functions recovered Rapid diagnosis and attentive management of patients is crucial because early deterioration is common Neurosurgical treatment for ICH has been discussed in recent multicentric studies, but no definitive answer of its utility has emerged.

Improved surgical techniques , neuroimaging, neuroanesthesia and perioperative monitoring and care have all led to improved outcomes from surgery

Study Type

Observational

Enrollment (Estimated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Mohamed Abd elbaset, Proffesseur
  • Phone Number: 01006071988
  • Email: Khallaf@aun.edu.eg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Any adult patient of both sexes admitted to neurosurgery Department with non traumatic BG hemorrhage with total coverage of 1 year

Description

Inclusion Criteria:

  • 1) patients aged between 15 and 60 years old ( elderly people>60 years were excluded since their strokes weren't routinely examined by CT scan in the emergency ward, however, in children<15 years old was due mostly to vascular malformations 2) CT scan showed basal ganglionic haemorrhage, with or without intraventricular extension within 24 hr post ictus 3) hematoma volume was 30 ml or above 4) Glasgow Coma Scale scores more than or equal 5 and stable vital signs

Exclusion Criteria:

  • 1) intracerebral hemorrhage was caused by secondary factors e.g ( vascular malformations or head trauma) 2) GCS less than 5 or multiple intracranial hemorrhage 3) associated visceral disease e.g hepatic or renal or clotting disorder 4) patients with preexisting neurological deficit e.g previous intracerebral hemorrhage or infarction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prognostic factors of surgical evacuation of basal ganglionic haemorrhage
Time Frame: Baseline
To investigate the effect of different factors on the outcome of the surgical evacuation of basal ganglionic haemorrhage
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Chair: Farrag Mohamed, Doctor, Assiut University neurosurgery Department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

March 7, 2024

First Submitted That Met QC Criteria

March 7, 2024

First Posted (Actual)

March 13, 2024

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Basal ganglionic haemorrhage

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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