Status:
WITHDRAWN
An Observational Study of Early Coagulopathy, or Clotting Disorder, in Injured Patients
Lead Sponsor:
Emory University
Conditions:
Trauma-induced Coagulopathy
Eligibility:
All Genders
18+ years
Brief Summary
Trauma continues to be the major killer of young Americans, mainly due to hemorrhage or brain injury. In trauma centers, up to a quarter of these severely injured patients arrive with a coagulopathy a...
Eligibility Criteria
Inclusion
- \> 17 years of age
- GMH Emergency Care Center (ECC) admission with trauma team activation - referred to by GMH nomenclature as a "STAT-pack." Trauma team activation criteria were developed from standard criteria published by the American College of Surgeons Committee on Trauma and published in Resources for Optimal Care of the Injured Patient manual 2006 edition and modified for GMH use. A trauma patient is declared a STAT-pack if they meet one of the following criteria:
- Ejection from a motor vehicle or motorcycle
- Extremes of age: pediatric \< 6 years of age or an adult \> 65 yrs of age
- One of the following: HR \> 120; RR \> 30; Systolic BP \< 100; GCS \< 13; Basal temperature \< 35 degrees C
- Penetrating trauma to head/neck/thorax/abdomen including flank and back/antecubital fossa/groins/popliteal space
- Suspected neurological injury i.e. spinal cord injury
- Traumatic amputation above the wrist or ankle
- Mangled or crush to an extremity
- History of trauma in a patient who is combative, has deteriorating vital signs or is hemorrhaging from an open wound
- Physician or EMS discretion
- Patients admitted to GMH ECC directly from the site of injury
Exclusion
- \< 18 years of age
- Any patient who is pronounced dead by health care personnel prior to any blood sampling
- Any patient who arrives undergoing CPR and is pronounced dead without resumption of vital signs
- Transfers from other health care facilities
- Any patient known to be taking anti-coagulant or anti-platelet medicine
- Any patient with a known predisposing history of a coagulation or platelet defect
Key Trial Info
Start Date :
July 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00744003
Start Date
July 1 2008
End Date
July 1 2009
Last Update
November 18 2013
Active Locations (1)
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1
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303