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

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ClinicalTrials.gov Identifier: NCT01589172
Recruitment Status : Unknown
Verified May 2015 by David K. Shellington, MD, University of California, San Diego.
Recruitment status was:  Recruiting
First Posted : May 1, 2012
Last Update Posted : May 29, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease
Traumatic Brain Injury Coagulation Disorder

Study Design

Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluating the Use of Thromboelastography to Diagnose and Monitor Coagulopathy Associated With Pediatric Traumatic Brain Injury
Study Start Date : May 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Pediatric Brain Trauma Patients


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 15 Years   (Child)
Sexes Eligible for Study:   All
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: May 1, 2012    Key Record Dates
Last Update Posted: May 29, 2015
Last Verified: May 2015

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