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

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ClinicalTrials.gov Identifier: NCT02475226
Recruitment Status : Completed
First Posted : June 18, 2015
Last Update Posted : June 18, 2015
Sponsor:
Information provided by (Responsible Party):
Gulsah Karaoren, Umraniye Education and Research Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Brain Injuries Other: type of the brain injury

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
Actual Enrollment : 135 participants
Observational Model: Case-Crossover
Time Perspective: Retrospective
Official Title: Distribution and Mortality Factors of Cases With Traumatic and Non Traumatic Brain Damage Treated in Intensive Care; Retrospective Clinical Trial
Study Start Date : April 2015
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

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




Primary Outcome Measures :
  1. number of patients by brain damage types [ Time Frame: 2 years ]
    distribution of the patients with brain damage over the brain damage reasons


Secondary Outcome Measures :
  1. Number of factors effecting the mortality [ Time Frame: 2 years ]
    duration time of intubation, duration time in the ICU, APACHE scores, GCS scores.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02475226


Locations
Turkey
Istanbul Umraniye Education and Research Hospital
Istanbul, Turkey
Sponsors and Collaborators
Umraniye Education and Research Hospital
Investigators
Study Chair: Nurten Bakan, MD Umraniye training and research hospital

Publications of Results:
Responsible Party: Gulsah Karaoren, MD, Umraniye Education and Research Hospital
ClinicalTrials.gov Identifier: NCT02475226     History of Changes
Other Study ID Numbers: GK7
First Posted: June 18, 2015    Key Record Dates
Last Update Posted: June 18, 2015
Last Verified: June 2015

Keywords provided by Gulsah Karaoren, Umraniye Education and Research Hospital:
Traumatic Brain Injury
Brain Damage
Mortality
C10.228.140.199

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries