Patients requiring veno-arterial extracorporeal circulation Circulatory System
Conditions
Interventions
The research protocol for evaluating Drainage and Return Cannulas is structured as a comprehensive two-phase study, the first aimed at ensuring safety and the second aimed at evaluating the performanc
Sponsors
Eurosets (Italy)
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Written informed consent or emergency enrolment under EU Reg. 536/2014, Art. 35. 2. Age = 18 years 3. Body surface area 1.4–2.5 m² 4. Requirement for VA-ECC (including VA-ECMO)
Exclusion criteria
Exclusion criteria: 1. Chronic hemodialysis 2. Diabetes mellitus 3. Hematological disease or history of thrombophilia 4. Pregnancy or breastfeeding 5. Active/metastatic malignancy 6. Severe CNS injury or intracranial hemorrhage 7. Anatomical abnormalities preventing participation 8. Uncontrolled active bleeding before ECC 9. Severe clinical condition interfering with participation 10. Participation in another interventional trial within 30 days 11. Advance directives excluding ECMO/ECC 12. Inability to comply with follow-up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Phase I (Safety): Number and type of adverse events related to the investigational device to be collected via eCRF from investigator reports, clinical assessments, and patient medical records during ECC and up to 2 days post-weaning. 2. Phase II (Non-inferiority): This phase has two co-primary endpoints: 2.1. Multistage Venous Femoral Cannulae – Drainage Pressure Performance measured using continuous ECC circuit pressure transducers recorded in the eCRF at 1h (V1), 6h (V2), regular intervals (VxM/VxA), and pre-weaning (Vy) 2.2. Return Cannulae – Reinfusion Pressure Performance measured using continuous ECC circuit pressure transducers recorded in the eCRF at 1h (V1), 6h (V2), regular intervals (VxM/VxA), and pre-weaning (Vy) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Phase I: Pilot Stage. Drainage and reinfusion pressures relative to blood flow rate measured using ECC monitoring system and eCRF during the ECC procedure (V1–Vy) 2. Phase II: Pivotal Stage. 2.1. Tissue Perfusion: Blood lactate levels measured using blood sample analysis from arterial line at baseline (V0), 1h (V1), 6h (V2), and at ECC end (Vy) 2.2. ECC Procedure Duration: Total procedure time (hours/minutes) measured using ECC start, and weaning times recorded in eCRF at pre-weaning (Vy) 2.3. User Friendliness: Cannulation and decannulation difficulty measured using a 5-point Likert scale completed by the physician at V1 (cannulation) and at decannulation (Vy) 2.4. Cannula Integrity: Structural integrity (Yes/No) measured using a visual inspection at decannulation (Vy) 2.5. Presence of Clots or Thrombi: Evidence of clot formation (Yes/No) measured using a visual inspection at decannulation (Vy) 2.6. Cannulation Site Complications: measured using clinical examination and medical record review throughout ECC and at follow-up visits (Vz, Vw) 2.7. Hospital Stay: measured using medical records and eCRF data at discharge (Vw) 3. Safety Endpoints 3.1. Clinical Parameters Monitoring measured using Standard patient monitoring devices during ECC and at all visits (V0–Vw) 3.2. Device Performance measured using Operator report and eCRF documentation at pre-, during, and post-cannulation (V0–Vy) 3.3. Adverse Events measured using Investigator assessment and eCRF report from baseline (V0) to end of study (Vw) 3.4. Concomitant Medications measured using a review of patient records and eCRF documentation from screening (V0) through follow-up (Vw) | — |
Countries
Italy
Contacts
Public ContactLetizia Bellesia
Outcome results
None listed