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 @ 4:29 AM
Ignite Modification Date:
2025-12-25 @ 4:29 AM
NCT ID:
NCT03366220
Eligibility Criteria:
Inclusion Criteria:
* Patients meeting the following criteria will be enrolled: Have a Sepsis Screening Score (SSS) ≥ 4 with a suspected source of infection (Table 1); and Written informed consent obtained
* Patients meeting any of the following criteria will be randomized: Hypotension with MAP \< 65 mmHg; Lactic acid \> 4 mmol/L; Altered mental status; and Decreased urine output of \< 0.5 mL/kg in the past hour.
Exclusion Criteria:
* Pregnancy
* Prisoners
* Traumatic brain injury
* Evidence of ongoing hemorrhage, history of congenital bleeding disorders, therapeutic anticoagulation
* History of myocardial infarction or congestive heart failure
* History of acute cerebral vascular event
* Major burns (\>20% total body surface area)
* History of adverse reactions to blood product transfusion
* Contraindications to blood transfusions (eg. Jehovah's Witness)
* Contraindications to central venous line and arterial line placement
* On intermittent hemodialysis
* Do-Not-Resuscitate or Comfort Care status
* Participation in another interventional study
* Pending transfer to another unit within the hospital that is not STICU or SIMU
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03366220
Study Brief:
Protocol Section:
NCT03366220