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Managing Severe Traumatic Brain Injury (TBI) Without Intracranial Pressure Monitoring (ICP) Monitoring Guidelines

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of Washington
Sponsor:
Information provided by (Responsible Party):
Randall M. Chesnut, University of Washington
ClinicalTrials.gov Identifier:
NCT02059941
First received: February 7, 2014
Last updated: February 10, 2014
Last verified: February 2014

February 7, 2014
February 10, 2014
August 2013
January 2017   (final data collection date for primary outcome measure)
Cognitive Function Scales [ Time Frame: up to six months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT02059941 on ClinicalTrials.gov Archive Site
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Managing Severe Traumatic Brain Injury (TBI) Without Intracranial Pressure Monitoring (ICP) Monitoring Guidelines
Managing Severe Traumatic Brain Injury (TBI) Without Intracranial Pressure Monitoring (ICP)- Guidelines Development and Testing

Management of intracranial hypertension (ICH) in patients with severe traumatic brain injury (sTBI) is crucial to their survival and optimal recovery. The evidence-based Guidelines for the Management of Severe Traumatic Brain Injury, 3rd Edition recommends use of intracranial pressure (ICP) monitors to assess ICH and guide intervention. Unfortunately, only a small percentage of the world has the resources and capability to routinely monitor ICP.

The objective of this proposal is to create and test guidelines for the treatment of severe TBI in the absence of ICP monitoring.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

In this study, there will be about 780 study subjects from 14 sites in Latin America. Subjects will be about 390 from clinical sites previously exposed to protocols for management of TBI, and about 390 from sites without prior exposure to protocols. Half of the study subjects (about 390 total) will be treated in accordance with a consensus-based protocol. Subjects will consist of patients with TBIs sufficiently severe to fulfill the inclusion criteria. To qualify, patients must be 13 or older and have a non-penetrating traumatic brain injury. The major criterion is severe TBI to be treated without the use of intracranial pressure monitoring

Traumatic Brain Injury
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
780
July 2017
January 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Non-penetrating TBI
  • Post-resuscitation Glasgow Coma Scale score (GCS) ≤ 8, and GCS Motor score ≤ 5, or Deterioration to those values within 48 hours of injury
  • Age 13 years or older
  • Consent to participate signed by Legally Authorized Representative (LAR)

Exclusion Criteria:

  • GCS of 3 with bilateral fixed and dilated pupils and/or decision to not actively treat prior to enrolment into study
  • Prisoner
  • No consent
  • Non-survivable injury
  • Other (e.g., Pre-injury life expectancy under 1 year)
  • Pre-existing neurological disability that would not allow follow-up
Both
13 Years and older
No
Contact: Silvia Lujan, MD 549-341-560-9239 silviablujan@gmail.com
Contact: Gustavo Petroni, MD 549-341-485-5074 gustavopetroni@gmail.com
Bolivia,   Colombia,   Ecuador,   Venezuela
 
NCT02059941
44679-J
No
Randall M. Chesnut, University of Washington
University of Washington
Not Provided
Principal Investigator: Randall M Chesnut, MD University of Washington
University of Washington
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP