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 @ 5:54 PM
Ignite Modification Date:
2025-12-24 @ 5:54 PM
NCT ID:
NCT04667468
Eligibility Criteria:
Inclusion Criteria:
Patients with traumatic injury who meet the following criteria:
1. Has 2 or more of any of the following:
1. Hypotension (systolic blood pressure ≤ 90 mmHg) in the prehospital or emergency department setting
2. Penetrating mechanism
3. Abdominal or Extended Focused Assessment with Sonography for Trauma (FAST) abdominal ultrasound is positive or equivocal or deferred by clinical team due to emergent visit to Interventional Radiology or a need for emergent laparotomy, thoracotomy, or vascular exploration
4. Heart rate ≥ 120 in the prehospital or emergency department setting
AND
2. Clinical team deems Operating Room (laparotomy, thoracotomy or vascular exploration) or Interventional Radiology for embolization within 60 minutes of arrival to be clinically indicated.
Exclusion Criteria:
1. Wearing "NO CriSP" opt-out bracelet
2. Age \>90 or \<15 years of age
3. Isolated fall from standing injury mechanism
4. Prisoner
5. Pregnant
6. Traumatic arrest with \>5 minutes of CPR without return of vital signs
7. Brain matter exposed or penetrating brain injury (gun shot wound \[GSW\])
8. Isolated drowning or hanging victims
9. Isolated burns \> estimated 20% total body surface area
10. Objection to study voiced by subject or family member in Emergency Department
Inclusion and exclusion criteria will be assessed based on information available at the time of enrollment. If, after subsequent review, it is determined that the subject did not meet inclusion criteria and/or met exclusion criteria, the subject will remain enrolled in the study based on the intent-to-treat principle.
If a verbal report must be used in lieu of physical documentation or directly witnessing inclusion criteria, documentation of the verbal report will serve as the source documentation for determining eligibility.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Maximum Age:
90 Years
Study:
NCT04667468
Study Brief:
Protocol Section:
NCT04667468