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 @ 6:51 PM
Ignite Modification Date:
2025-12-24 @ 6:51 PM
NCT ID:
NCT05796557
Eligibility Criteria:
Inclusion Criteria:
* Critically ill children (0 to \<18 years of age)
* Admitted to a participating pediatric, neonatal, or cardiac intensive care unite (PICU/NICU/CICU)
* On extracorporeal Membrane Oxygenation (ECMO)
* Who have either no bleeding or minimal bleeding, within 24 hours of cannulation. Minimal bleeding is defined as:
* streaks of blood in endotracheal tube or during suctioning only
* streaks of blood in nasogastric tube
* macroscopic hematuria
* subcutaneous bleeding (including hematoma and petechiae) \< 5 cm in diameter
* quantifiable bleeding \< 1mL/kg/hr (e.g., chest tube)
* bloody dressings required to be changed no more often than each 6hr, or weighing no more than 1mL/kg/hr if weighed, due to slow saturation
Exclusion Criteria:
* Post-conception age \< 37 weeks at time of screening
* Underlying oncologic diagnosis (defined as receipt of chemotherapy or radiation in the last six months) or recipient of bone marrow transplant in the last year
* Congenital bleeding disorder
* Pregnant or admitted post-partum
* Decision to withdraw or withhold some critical care or interventions
* Known objection to blood transfusions
* On ECMO for \> 24 hours at time of enrollment
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
18 Years
Study:
NCT05796557
Study Brief:
Protocol Section:
NCT05796557