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
  Purpose

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.


Condition
Traumatic Brain Injury

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Managing Severe Traumatic Brain Injury (TBI) Without Intracranial Pressure Monitoring (ICP)- Guidelines Development and Testing

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Cognitive Function Scales [ Time Frame: up to six months ] [ Designated as safety issue: No ]

Estimated Enrollment: 780
Study Start Date: August 2013
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02059941

Contacts
Contact: Silvia Lujan, MD 549-341-560-9239 silviablujan@gmail.com
Contact: Gustavo Petroni, MD 549-341-485-5074 gustavopetroni@gmail.com

Locations
Bolivia
Hospital Viedma Not yet recruiting
Cochabamba, Bolivia
Contact: Luis A Lavadenz, MD    591-72709559      
Contact: Siliva Lujan, MD    549-3414855074    silviablujan@gmail.com   
Hospital San Juan de Dios Not yet recruiting
Santa Cruz de la Sierra, Bolivia
Contact: Victor Alanis, MD    591-70299888      
Contact: Silvia Lujan, MD    549-3415609239    silviablujan@gmail.com   
Hospital Japones Active, not recruiting
Santa Cruz de la Sierra, Bolivia
Hospital San Juan de Dios Recruiting
Tarija, Bolivia
Contact: Roberto M Merida, MD    59170215050      
Contact: Siliva Lujan, MD    549-3415609329    silviablujan@gmail.com   
Colombia
Fundacion Clinica Campbell Recruiting
Barranquilla, Colombia
Contact: Ricardo Romero, MD    573-1845392258      
Contact: Silvia Lujan, MD    549-3415609230    silviablujan@gmail.com   
Clinica Universitaria Rafael Uribe Recruiting
Cali, Colombia
Contact: Oscar Pinillos, MD    301-3765951      
Contact: Silvia Lujan, MD    549-3415609239    silviablujan@gmail.com   
Hospital Erasmo Meoz #1 Recruiting
Cucuta, Colombia
Contact: Zulma Urbina, MD    573-134414353      
Contact: Silvia Lujan, MD    549-3415609239    silviablujan@gmail.com   
Hospital Erasmo Meoz #2 Recruiting
Cucuta, Colombia
Contact: Jairo Figeroa, MD    573-3138534218      
Contact: Silvia Lujan, MD    549-3415609239    silviablujan@gmail.com   
Ecuador
Hospital Jose Carrasco Arteaga Recruiting
Cuenca, Ecuador
Contact: Soraya Puertas, MD    593-99246924      
Contact: Silvia Lujan, MD    549-3415609239    silviablujan@gmail.com   
Hospital Espejo Recruiting
Quito, Ecuador
Contact: Manuel E Jibaja, MD    593-99668588      
Contact: Silvia Lujan, MD    549-3415609239    silviablujan@gmail.com   
Venezuela
Hospital Luis Razetti Recruiting
Barcelona, Venezuela
Contact: Jacobo Mora, MD    58-4142471196      
Contact: Silvia Lujan, MD    549-3415609239    silviablujan@gmail.com   
Hospital Luis Razetti Recruiting
Barinas, Venezuela
Contact: Rafael Davila    58-41456703      
Contact: Silvia Lujan, MD    549-3415609239    silviablujan@gmail.com   
Hospital Dr. Patrocinio Penuela Ruiz Recruiting
Cristobal, Venezuela
Contact: Giannina B Martinez, MD    58-4147119190      
Contact: Silvia Lujan, MD    549-3415609239    silviablujan@gmail.com   
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Randall M Chesnut, MD University of Washington
  More Information

No publications provided

Responsible Party: Randall M. Chesnut, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT02059941     History of Changes
Other Study ID Numbers: 44679-J
Study First Received: February 7, 2014
Last Updated: February 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
Severe traumatic brain injury, intracranial hypertension, Latin America, observational study, outcomes assessments

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

ClinicalTrials.gov processed this record on July 29, 2014