We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2015 by David K. Shellington, MD, University of California, San Diego.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01589172
First Posted: May 1, 2012
Last Update Posted: May 29, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
David K. Shellington, MD, University of California, San Diego
  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:


Further study details as provided by David K. Shellington, MD, University of California, San Diego:

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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
Information from the National Library of Medicine

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 Submitted: April 27, 2012
First Posted: May 1, 2012
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