Cases With Traumatic and Non Traumatic Brain Damage Treated in the Intensive Care

June 17, 2015 updated by: Gulsah Karaoren, Umraniye Education and Research Hospital

Distribution and Mortality Factors of Cases With Traumatic and Non Traumatic Brain Damage Treated in Intensive Care; Retrospective Clinical Trial

Cases of traumatic and nontraumatic brain damage have high rates of morbidity and mortality. In this study of cases being treated in the ICU for a diagnosis of brain damage, it was aimed to evaluate the relationship between mortality and the distribution of reason for and resulting type of brain damage and to determine other factors affecting mortality.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After local ethics committee approval, a total of 1004 patients treated in the ICU in a 2-year period were retrospectively reviewed. 135 patients, determined with traumatic or nontraumatic brain damage, with a more than 24-hour stay in the ICU, included the study. Reasons for brain damage were determined as brain damage associated with pure head trauma (Group HT), head trauma accompanying general body trauma (Group HT+GBT) and spontaneous haemorrhage (Group SH). The type of brain damage was defined from the radiological diagnosis as subarachnoid haemorrhage, intracranial haemorrhage (ICH), subdural haematoma(SDH), epidural haematoma(EDH), skull fracture, brain contusion or a combination of these (COM).

Study Type

Observational

Enrollment (Actual)

135

Contacts and Locations

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

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Istanbul Umraniye Education and Research Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

a total of 1004 patients treated in the ICU in a 2-year period were retrospectivly reviewed. 135 patients, determined with traumatic or nontraumatic brain damage, with a more than 24-hour stay in the ICU, included the study.

Description

Inclusion Criteria:

  • Patients treated in the ICU with the diagnose of traumatic or nontraumatic brain damage, with a more than 24-hour stay.

Exclusion Criteria:

  • Patients admitted less than 24 hour.

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

  • Observational Models: Case-Crossover
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with body and head trauma
type of the brain injury in patients with brain damage associated both general body and head trauma
Other: type of the brain injury
epidural hematoma
Other: type of the brain injury
subdural hematoma
Other: type of the brain injury
subarachnoid hematoma
Other: type of the brain injury
intraparenchymal hematoma
Other: type of the brain injury
scull fracture
Other: type of the brain injury
brain contusion
Patients with pure head trauma
type of the brain injury in patients with brain damage associated pure head trauma
Other: type of the brain injury
epidural hematoma
Other: type of the brain injury
subdural hematoma
Other: type of the brain injury
subarachnoid hematoma
Other: type of the brain injury
intraparenchymal hematoma
Other: type of the brain injury
scull fracture
Other: type of the brain injury
brain contusion
Patients with spontaneous hemorrhage
type of the brain injury in Patients with brain damage associated spontaneous hemorrhage
Other: type of the brain injury
epidural hematoma
Other: type of the brain injury
subdural hematoma
Other: type of the brain injury
subarachnoid hematoma
Other: type of the brain injury
intraparenchymal hematoma
Other: type of the brain injury
scull fracture
Other: type of the brain injury
brain contusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of patients by brain damage types
Time Frame: 2 years
distribution of the patients with brain damage over the brain damage reasons
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of factors effecting the mortality
Time Frame: 2 years
duration time of intubation, duration time in the ICU, APACHE scores, GCS scores.
2 years

Collaborators and Investigators

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

Sponsor

Umraniye Education and Research Hospital

Investigators

  • Study Chair: Nurten Bakan, MD, Ümraniye Training and Research Hospital

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

April 1, 2015

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

June 15, 2015

First Submitted That Met QC Criteria

June 17, 2015

First Posted (Estimate)

June 18, 2015

Study Record Updates

Last Update Posted (Estimate)

June 18, 2015

Last Update Submitted That Met QC Criteria

June 17, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GK7

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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