NCT01077089

Brief Summary

Hospitalized patients are often moved from their rooms to other hospital locations, particularly imaging facilities. For patients with traumatic brain injury, such movements may raise the risk of secondary brain injuries. The purpose of this study is to monitor brain injured patients during transport and to measure the resulting changes in intracranial pressure. This will allow for documentation of the frequency of secondary injury and help in understanding their causes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2010

Typical duration 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

February 1, 2010

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

February 25, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 26, 2010

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

February 25, 2013

Status Verified

February 1, 2013

Enrollment Period

2.7 years

First QC Date

February 25, 2010

Last Update Submit

February 22, 2013

Conditions

Traumatic Brain Injury

Keywords

traumatic brain injuryIn-hospital transport

Outcome Measures

Primary Outcomes (1)

  • Incidence of adverse events during transport.

    Each transport event

Secondary Outcomes (7)

  • Incidence of elevated heart rate during transport.

    Each transport event

  • Incidence of transport events during which SpO2 remains below 90% for 1 minute or longer

    Each transport event

  • Transport events during which systolic blood pressure remains below 90 mmHg for 5 minutes or longer

    Each transport event

  • Transport events during which mean arterial blood pressure remains below 60 mmHg for 5 minutes or longer

    Each transport event

  • Transport events during which intracranial pressure exceeds 20 mmHg for 5 minutes or longer

    Each transport event

  • +2 more secondary outcomes

Study Arms (1)

Transported TBI patients

Traumatically brain injured patients undergoing in-hospital transport.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with traumatic brain injury

You may qualify if:

  • presence of traumatic brain injury and intracranial pressure monitoring
  • requiring mechanical ventilation
  • presence of an indwelling arterial catheter for monitoring blood pressure
  • Age of at least 18 years

You may not qualify if:

  • Age less than 18 years
  • diagnosis of brain death
  • non-English speakers
  • prisoners
  • mentally ill persons

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Cincinnati, Ohio, 45267, United States

Location

Related Publications (4)

  • Chesnut RM, Marshall LF, Klauber MR, Blunt BA, Baldwin N, Eisenberg HM, Jane JA, Marmarou A, Foulkes MA. The role of secondary brain injury in determining outcome from severe head injury. J Trauma. 1993 Feb;34(2):216-22. doi: 10.1097/00005373-199302000-00006.

    PMID: 8459458BACKGROUND

  • Chesnut RM, Marshall SB, Piek J, Blunt BA, Klauber MR, Marshall LF. Early and late systemic hypotension as a frequent and fundamental source of cerebral ischemia following severe brain injury in the Traumatic Coma Data Bank. Acta Neurochir Suppl (Wien). 1993;59:121-5. doi: 10.1007/978-3-7091-9302-0_21.

    PMID: 8310858BACKGROUND

  • Jeremitsky E, Omert L, Dunham CM, Protetch J, Rodriguez A. Harbingers of poor outcome the day after severe brain injury: hypothermia, hypoxia, and hypoperfusion. J Trauma. 2003 Feb;54(2):312-9. doi: 10.1097/01.TA.0000037876.37236.D6.

    PMID: 12579057BACKGROUND

  • Manley G, Knudson MM, Morabito D, Damron S, Erickson V, Pitts L. Hypotension, hypoxia, and head injury: frequency, duration, and consequences. Arch Surg. 2001 Oct;136(10):1118-23. doi: 10.1001/archsurg.136.10.1118.

    PMID: 11585502BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

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

Study Officials

  • Warren A Dorlac, MD

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Clinical-Geo

Study Record Dates

First Submitted

February 25, 2010

First Posted

February 26, 2010

Study Start

February 1, 2010

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

February 25, 2013

Record last verified: 2013-02

Locations

US(1)