NCT01589172

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 1, 2012

Completed
Same day until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2012

Completed
Last Updated

February 28, 2020

Status Verified

February 1, 2020

Enrollment Period

7 months

First QC Date

April 27, 2012

Last Update Submit

February 26, 2020

Conditions

Study Arms (1)

Pediatric Brain Trauma Patients

Eligibility Criteria

AgeUp to 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

Location

MeSH Terms

Conditions

Brain Injuries, TraumaticHemostatic Disorders

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesVascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • David K Shellington, MD

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

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

Locations