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 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT03145220
Eligibility Criteria:
Inclusion Criteria:
1. Patients scheduled for elective on-pump CABG surgery.
* Part 1: 60 patients undergoing CABG surgery, of which circa 40 low risk patients without valve replacement (range: 35-45)
* Part 2: CABG surgery with or without valve replacement
2. Written informed consent to participate in this trial prior to any study-mandated procedure.
3. Patients aged \>18, both male and female.
4. Patients have to agree to use a reliable way of contraception with their partners from study entry until 3 months after study drug administration.
Exclusion Criteria:
1. Immunocompromised
* Solid organ transplantation
* Known HIV
* Pregnancy
* Systemic use of immunosuppressive drugs
2. Non-elective/Emergency surgery
3. Hematological disorders
* Known disorders from myeloid and/or lymphoid origin
* Leucopenia (leucocyte count \< 4x109/L)
4. Known hypersensitivity to any excipients of the drug formulations used
5. Treatment with investigational drugs or participation in any other intervention clinical trial within 30 days prior to study drug administration
6. Inability to personally provide written informed consent (e.g. for linguistic or mental reasons)
7. Known or suspected of not being able to comply with the trial protocol.
In addition, for part 1 only (to select low-risk patients):
8. Euroscore II \<4
9. Kidney function impairment: serum creatinine \>200 µmol/L
10. Liver function impairment: Alanine transaminase/Aspartate transaminase (ALAT/ASAT) \>3 times above upper level of reference range
11. Left ventricular dysfunction: Ejection fraction\<35%
12. CABG procedure with valve replacement
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03145220
Study Brief:
Protocol Section:
NCT03145220