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

Tracking Information

First Received Date ^ICMJE

April 27, 2012

Last Updated Date

May 1, 2012

Start Date ^ICMJE

May 2012

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT01589172 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Evaluating the Use of Thromboelastography to Diagnose and Monitor Coagulopathy Associated With Pediatric Traumatic Brain Injury

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).

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

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

Condition ^ICMJE

Traumatic Brain Injury
Coagulation Disorder

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Pediatric Brain Trauma Patients

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

up to 15 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01589172

Other Study ID Numbers ^ICMJE

120296

Has Data Monitoring Committee

Responsible Party

David K. Shellington, MD, University of California, San Diego

Study Sponsor ^ICMJE

University of California, San Diego

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

David K Shellington, MD

University of California, San Diego

Information Provided By

University of California, San Diego

Verification Date

May 2012

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

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