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

NCT ID: NCT01589172

Last Updated: 2020-02-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-05-01
• Study Completion Date: 2012-11-30

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).

Conditions

Traumatic Brain Injury; Coagulation Disorder

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Pediatric Brain Trauma Patients

No interventions assigned to this group

Eligibility 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

• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David K Shellington, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

Rady Children's Hospital

San Diego, California, United States

Countries

United States

Other Identifiers

120296

Identifier Type: -

Identifier Source: org_study_id