Evaluating the Use of Thromboelastography to Diagnose Coa... | NCT01589172

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

NCT01589172

Sponsor

University of California, San Diego

Status

Completed

Last Update Posted

Feb 28, 2020Actual

Enrollment

40Actual

Phase

Not provided

Conditions

Traumatic Brain Injury
Coagulation Disorder

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2012Actual

Primary Completion Date

Nov 30, 2012Actual

Completion Date

Nov 30, 2012Actual

First Submitted Date

Apr 27, 2012

First Submission Date that Met QC Criteria

Apr 30, 2012

First Posted Date

May 1, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 26, 2020

Last Update Posted Date

Feb 28, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Label	Type	Description	Intervention Names
Pediatric Brain Trauma Patients

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

15 Years

Standard Ages

Child

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David K Shellington, MD	University of California, San Diego	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rady Children's Hospital		San Diego	California	92123	United States

Condition Browse Module

MeSH Terms

ID	Term
D000070642	Brain Injuries, Traumatic
D020141	Hemostatic Disorders

Ancestor Terms

ID	Term
D001930	Brain Injuries
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided