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 @ 9:21 PM
Ignite Modification Date:
2025-12-24 @ 9:21 PM
NCT ID:
NCT00462904
Eligibility Criteria:
Inclusion Criteria:
* Ages 13 years to 60 years old
* Sustained partial-thickness or full-thickness burn greater than 20% and less than 41% TBSA
* Parental consent (if subject is less than 18 years old) or individual (if subject is equal to or older than 18) signed, informed consent.
* Able to start BPI in infusion within 8 hours of burn injury.
Exclusion Criteria:
* Age \> 61.
* Inhalational injury requiring mechanical ventilation.
* Partial and full thickness burns totaling \> 41% total body surface area
* Cardiac dysfunction, defined as the presence of any of the following:
1. New York Heart Class 3 or 4 heart failure.
2. Unstable angina or acute myocardial infarction.
3. Left ventricular ejection fraction known to be \< 35%.
* Electrical or lightening induced burn injury or any injury that required cardio-pulmonary resuscitation.
* Concomitant non-burn trauma with an ISS \> 9.
* Non-survivable injury secondary to burn size - patients made DNR or comfort care due to burn size.
* Patients with known causes of immunosuppression:
1. Known history of HIV/AIDS
2. Chronic steroid use for underlying medical conditions (equivalent to 15 mg prednisone/day).
3. Active oncolytic therapy for known malignancy
* Known or suspected pregnancy
* Known allergy to rBPI21
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Maximum Age:
60 Years
Study:
NCT00462904
Study Brief:
Protocol Section:
NCT00462904