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:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-25 @ 3:27 AM
NCT ID:
NCT01227005
Eligibility Criteria:
Inclusion Criteria:
1. 18 years of age or older.
2. Meet Code 3 status; Code 3 is determined by the following criteria (Patients must meet at least one of the following physiologic and/or anatomic criteria):
* Physiologic criteria indicating high risk or life threatening injuries
* GCS \<10 (Glasgow Coma Scale)
* SBP \<90 (Systolic blood pressure)
* RR \<10 or \>29 (Respiratory rate)
* HR \>120 (Heart rate)
* intubated
* Base Deficit \> 6
* Anatomic criteria indicating high risk or life threatening injuries
* Any penetrating injury to torso, groin, or neck
* Amputation proximal to the ankle or wrist
* Uncontrolled external hemorrhage
* Two or more long bone fractures
* Pelvic fracture
* Paraplegia or quadriplegia
* Combination trauma with burns ≥ 20% BSA (body surface area)
3. Demonstrate evidence of blood loss due to injury, requiring transfusion in the ED.
Exclusion Criteria:
1. Death thought to be imminent, suggesting a futile resuscitation effort
2. Known or assumed religious objection to blood products
3. Do not resuscitate order in place
4. Women who present to the ED who are obviously pregnant.
5. Patients who appear to the ED wearing the -opt-out‖ bracelet provided at the community consultation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT01227005
Study Brief:
Protocol Section:
NCT01227005