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Evaluating the Use of Thromboelastography to Diagnose Coagulopathy After Traumatic Brain Injury

This study is currently recruiting participants.
Verified May 2012 by University of California, San Diego
Sponsor:
Information provided by (Responsible Party):
David K. Shellington, MD, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01589172
First received: April 27, 2012
Last updated: May 1, 2012
Last verified: May 2012
History of Changes
  Purpose

The investigators will obtain thromboelastography (TEG) on pediatric patients admitted to the Rady Children's Hospital ICU after traumatic brain injury on admission to our ICU and after 24 hours of care. The investigators hypothesize that TEG will identify abnormalities of coagulation that are not identified by traditional coagulation studies, i.e. prothrombin time (PT), activated partial thromboplastin time (aPTT), and international normalized ratio (INR).


Condition
Traumatic Brain Injury
Coagulation Disorder

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluating the Use of Thromboelastography to Diagnose and Monitor Coagulopathy Associated With Pediatric Traumatic Brain Injury

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, San Diego:

Estimated Enrollment: 40
Study Start Date: May 2012
Groups/Cohorts
Pediatric Brain Trauma Patients

  Eligibility

Ages Eligible for Study:   up to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Trauma patients admitted to the Rady Children's Hospital Pediatric Intensivse Care Unit

Criteria

Inclusion Criteria:

  • less than 15 years of age
  • evidence of intracranial bleed on CT scan or GCS <12

Exclusion Criteria:

  • No intracranial hemorrhage or
  • GCS 13 - 15
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01589172

Locations
United States, California
Rady Children's Hospital Recruiting
San Diego, California, United States, 92123
Contact: David K Shellington, MD     858-966-5863     dshellington@ucsd.edu    
Principal Investigator: David K Shellington, MD            
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: David K Shellington, MD University of California, San Diego
  More Information

No publications provided

Responsible Party: David K. Shellington, MD, Director Pediatric Critical Care Research, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01589172     History of Changes
Other Study ID Numbers: 120296
Study First Received: April 27, 2012
Last Updated: May 1, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Brain Injuries
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on May 21, 2013