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 @ 1:16 AM
Ignite Modification Date:
2025-12-25 @ 1:16 AM
NCT ID:
NCT04617093
Eligibility Criteria:
Inclusion Criteria:
1. Patient age is ≥ 18 years old
2. Patient is expected to receive ECCO2R for a minimum of 24 hours
3. Patient has mild or moderate ARDS according to the Berlin definition:
* 100 mm Hg \< PaO2/FiO2 ≤ 300 mm Hg, with PEEP ≥ 5 cm H2O, and
* Bilateral lung opacities not fully explained by effusions, lobar/lung collapse, or nodules, and
* Respiratory failure not fully explained by cardiac failure or fluid overload
4. Written informed consent to participate in the study from the patient, if possible, or from the identified authorized representative if the patient is unable to provide consent.
Exclusion Criteria:
1. Patients body weight \< 30 kg
2. Patients with a contraindication for systemic anticoagulation with heparin
3. Patients with a platelet count \< 50,000/µL
4. Patients on MV \> 7 days
5. Patients with very severe, or stage 4 (as per GOLD staging System) chronic obstructive pulmonary disease (COPD)
6. Current or history of heparin-induced thrombocytopenia
7. Patients who are pregnant and/or breastfeeding
8. Patients not expected to survive the duration of the planned study treatment period (24 hours)
9. Patients currently participating in another interventional clinical study, except if the patient is in an investigational medicinal product study, already in follow-up without further administration of study drug, and has not received any investigational medicinal product within 5 half-lives
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04617093
Study Brief:
Protocol Section:
NCT04617093