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 @ 10:45 PM
Ignite Modification Date:
2025-12-24 @ 10:45 PM
NCT ID:
NCT03402035
Eligibility Criteria:
Inclusion Criteria:
Patients with blunt or penetrating injury who meet the following criteria: 1, 2, and 3
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. Positive FAST abdominal ultrasound,
4. Heart Rate ≥ 120 in the prehospital or emergency department setting.
AND
2. Taken to the Operating Room (laparotomy, thoracotomy or vascular exploration) or Interventional Radiology within 60 minutes of arrival.
AND
3. Need of blood/blood component transfusion in prehospital setting, ED or OR within 60 minutes of arrival.
Exclusion Criteria:
1. Age ≤ 14
2. CPR \> 5 consecutive minutes without ROSC
3. Penetrating brain injury with brain matter exposed
4. ED death
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Maximum Age:
90 Years
Study:
NCT03402035
Study Brief:
Protocol Section:
NCT03402035