Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:40 PM
Ignite Modification Date:
2025-12-24 @ 7:40 PM
NCT ID:
NCT00744003
Eligibility Criteria:
Inclusion Criteria:
1. \> 17 years of age
2. 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
3. Patients admitted to GMH ECC directly from the site of injury
Exclusion Criteria:
1. \< 18 years of age
2. Any patient who is pronounced dead by health care personnel prior to any blood sampling
3. Any patient who arrives undergoing CPR and is pronounced dead without resumption of vital signs
4. Transfers from other health care facilities
5. Any patient known to be taking anti-coagulant or anti-platelet medicine
6. Any patient with a known predisposing history of a coagulation or platelet defect
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00744003
Study Brief:
Protocol Section:
NCT00744003