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 @ 7:49 PM
Ignite Modification Date:
2025-12-24 @ 7:49 PM
NCT ID:
NCT01881503
Eligibility Criteria:
Inclusion Criteria:
1. Patients \> = 18 years of age
2. Patients with hemoglobin \< = 8g/dL with with active bleeding, physiologic evidence of critical ischemia, for example: elevated troponins, altered mental status, acute renal failure, lactic acidosis or central nervous system supply dependency
3. Patients or their Legally Authorized Representatives who are able and willing to provide informed consent
Exclusion Criteria:
1. Patients with known hypersensitivity or allergy to beef products
2. Patients with pre-existing uncontrolled hypertension, heart failure, renal failure, circulatory hypervolemia or systemic mastocytosis (on a case by case and quality of life determination)
3. Patients \> 80 years of age (on a case by case and quality of life determination)
4. Patients who are eligible for blood transfusions
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01881503
Study Brief:
Protocol Section:
NCT01881503