Evaluating the Use of Thromboelastography to Diagnose Coagulopathy After Traumatic Brain Injury
1 other identifier
observational
40
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2012
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 27, 2012
CompletedFirst Posted
Study publicly available on registry
May 1, 2012
CompletedStudy Start
First participant enrolled
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2012
CompletedFebruary 28, 2020
February 1, 2020
7 months
April 27, 2012
February 26, 2020
Conditions
Study Arms (1)
Pediatric Brain Trauma Patients
Eligibility Criteria
Trauma patients admitted to the Rady Children's Hospital Pediatric Intensivse Care Unit
You may qualify if:
- less than 15 years of age
- evidence of intracranial bleed on CT scan or GCS \<12
You may not qualify if:
- No intracranial hemorrhage or
- GCS 13 - 15
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rady Children's Hospital
San Diego, California, 92123, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David K Shellington, MD
University of California, San Diego
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2012
First Posted
May 1, 2012
Study Start
May 1, 2012
Primary Completion
November 30, 2012
Study Completion
November 30, 2012
Last Updated
February 28, 2020
Record last verified: 2020-02