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 @ 3:45 AM
Ignite Modification Date:
2025-12-25 @ 3:45 AM
NCT ID:
NCT05534802
Eligibility Criteria:
Inclusion Criteria:
1. Voluntarily sign the informed consent;
2. Age ≥18 years old and ≤70 years old;
3. Patients receiving cardiopulmonary bypass
4. Patients undergoing heart valve replacement surgery, major vascular surgery, and other cardiac surgery
Exclusion Criteria:
1. Severe cardiac insufficiency before surgery (EF\<50%, cardiogenic shock);
2. Patients with adverse events during surgery (such as cardiac arrest, etc.);
3. Solid organ or bone marrow transplant recipients;
4. pregnant women;
5. Have a history of allergy to ulinastatin or any of its ingredients;
6. Suffering from autoimmune diseases, tumors, or received high-dose hormones, immunosuppressive drugs, etc. within 2 months;
7. The researcher judges that it is not suitable to participate in this research.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05534802
Study Brief:
Protocol Section:
NCT05534802