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

Brain Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02475226
• Other study ID #: GK7
• Status: Completed
• Phase: N/A
• First received: June 15, 2015
• Last updated: June 17, 2015
• Start date: April 2015
• Est. completion date: May 2015

Study information

• Verified date: June 2015
• Source: Umraniye Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Crossover, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Brain Injuries

Intervention

Other:
• type of the brain injury
epidural hematoma
• type of the brain injury
subdural hematoma
• type of the brain injury
subarachnoid hematoma
• type of the brain injury
intraparenchymal hematoma
• type of the brain injury
scull fracture
• type of the brain injury
brain contusion

Locations

Country	Name	City	State
Turkey	Istanbul Umraniye Education and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Umraniye Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Sacco S, Marini C, Toni D, Olivieri L, Carolei A. Incidence and 10-year survival of intracerebral hemorrhage in a population-based registry. Stroke. 2009 Feb;40(2):394-9. doi: 10.1161/STROKEAHA.108.523209. Epub 2008 Nov 26. — View Citation

Schwarz S, Häfner K, Aschoff A, Schwab S. Incidence and prognostic significance of fever following intracerebral hemorrhage. Neurology. 2000 Jan 25;54(2):354-61. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of patients by brain damage types	distribution of the patients with brain damage over the brain damage reasons	2 years	Yes
Secondary	Number of factors effecting the mortality	duration time of intubation, duration time in the ICU, APACHE scores, GCS scores.	2 years	Yes