A Prospective Phase 1 Study of a Novel Bi-Directional Arterial Cannula in Patients requiring Peripheral Veno-Arterial Extra Corporeal Membrane Oxygenation (VA-ECMO) Support.

Phase 1

• Conditions: Patients who require peripheral cannulation for Veno-Arterial Extra Corporeal Membrane Oxygenation.; Heart Failure; Cardiovascular - Coronary heart disease

• Registration Number: ACTRN12615001086550
• Lead Sponsor: The Alfred Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-10-15
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1.Must be between18 years and 80 years inclusive.
2. Assessed as requiring V-A ECMO support by ICU consultant
3. Must weigh between 45kg and 130kg inclusive.
4. Site personel must obtain written informed consent from the patient or their legally authorised representative prior to any study procedures

Exclusion Criteria

Patients with a history of peripheral vascular disease
-previous peripheral arterial bypass
-diabetic vasculopathy
2. Patients with a history of diabetic retinopathy
3. Patients with a history of diabetic nephropathy
4. Patients where the common femoral artery is not identifiable with vascular ultrasound.
5. Patients where the common femoral artery is identifiable with vascular ultrasound but the internal diameter of the femoral artery is not greater than 0.6cm.
6.Patients requiring ECMO support to be instituted in the emergency setting during Cardio Pulmonary Resuscitation (CPR).
7. Non Alfred Hospital VA ECMO initiation (retrieval)
8. Concurrent enrolment in another investigational drug or device study, or use of any experimental or investigational drug or device within 30 days of ECMO support.
9. Any other medical condition which in the view of the investigator is likely to interfere with the study or put the participant at risk.
10. Patients who the investigator feels may not achieve adequate flow rates and line pressures due to their weight or body height.

Study & Design

• Study Type: Interventional
• Study Design: Not specified