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 @ 9:15 PM
Ignite Modification Date:
2025-12-24 @ 9:15 PM
NCT ID:
NCT00316004
Eligibility Criteria:
Inclusion Criteria:
* Blunt trauma
* Pre-hospital Glasgow Coma Scale equal to or less than 8(GCS≤8)\*
* Age 15 years or older or 50 kg or more
* Patients who met the inclusion criteria above and did not meet the exclusion criteria below but who had systolic blood pressure (SBP) ≤70 or SBP\>70 and SBP≤90 and heart rate (HR)≥108 were included in the Hypertonic Resuscitation following Traumatic Injury study that focused on shock patients who may or may not have a traumatic brain injury (TBI). In other words, patients with both TBI and shock would not be included in this study of TBI patients without shock at the time of enrollment.
Exclusion Criteria:
* Known or suspected pregnancy
* Age younger than 15 years or less than 50 kg if age unknown
* Ongoing pre-hospital cardiopulmonary resuscitation (CPR)
* Administration of more than 2L crystalloid or any colloid or blood products
* Severe hypothermia (T less than 28C)
* Drowning or asphyxia due to hanging
* Burns TBSA more than 20%
* Isolated penetrating injury to the head
* Inability to obtain pre-hospital intravenous access
* Time of call received at dispatch to study intervention more than four hours
* Known prisoners
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Study:
NCT00316004
Study Brief:
Protocol Section:
NCT00316004