NCT02475226

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 18, 2015

Completed
Last Updated

June 18, 2015

Status Verified

June 1, 2015

Enrollment Period

1 month

First QC Date

June 15, 2015

Last Update Submit

June 17, 2015

Conditions

Keywords

Traumatic Brain InjuryBrain DamageMortalityC10.228.140.199

Outcome Measures

Primary Outcomes (1)

  • number of patients by brain damage types

    distribution of the patients with brain damage over the brain damage reasons

    2 years

Secondary Outcomes (1)

  • Number of factors effecting the mortality

    2 years

Study Arms (3)

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

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

Patients with spontaneous hemorrhage

type of the brain injury in Patients with brain damage associated spontaneous hemorrhage

Other: type of the brain injury

Interventions

epidural hematoma

Patients with body and head traumaPatients with pure head traumaPatients with spontaneous hemorrhage

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Patients admitted less than 24 hour.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Umraniye Education and Research Hospital

Istanbul, Turkey, Turkey (Türkiye)

Location

Related 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.

  • Schwarz S, Hafner K, Aschoff A, Schwab S. Incidence and prognostic significance of fever following intracerebral hemorrhage. Neurology. 2000 Jan 25;54(2):354-61. doi: 10.1212/wnl.54.2.354.

MeSH Terms

Conditions

Brain InjuriesBrain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Nurten Bakan, MD

    Umraniye Education and Research Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 15, 2015

First Posted

June 18, 2015

Study Start

April 1, 2015

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

June 18, 2015

Record last verified: 2015-06

Locations