ThrombosisBlood Coagulation DisorderPlatelet ThrombusPlatelet Dysfunction Due to AspirinFailure;Ventricular
Investigational drug(s) / intervention(s)
PAS assay, TGT
PAS assay, TGT: Evaluation of platelet function
Study summary
Consenting patients with end-stage heart failure that are implanted with/candidates for implant of a short-term/durable mechanical circulatory support device (e.g.: percutaneous microaxial pumps (Impella), extracorporeal membrane oxygenator (ECMO), Ventricular Assist Device (VAD) will be enrolled in the study.
Aim of the study is to evaluate the patients' haemostatic and coagulation profile, how it interacts with the support device as well as the effect of antithrombotic drugs. From these data, it will be possible to derive the mechanisms triggering post-implant thromboembolic/hemorrhagic complications and to identify potential therapeutic targets.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
Accepted
Inclusion Criteria:
* All consenting patients candidates for short-term (Impella, ECMO) or durable (LVAD) mechanical circulatory support device implantation
* All consenting patients that are implanted with short-term (Impella, ECMO) or durable (LVAD) mechanical circulatory support device
Exclusion Criteria:
\- Patients \< 18-years old
Primary outcome measure(s)
Number of participants with treatment-related adverse events. Change of PAS assay from baseline to 24 months post-implant — Through study completion. Specific time-points: 1, 3, 6, 12, 18, and 24 months post-implant and at the occurrence of any AE Correlation between platelet activation and the development of post-implant complications
Number of participants with treatment-related adverse events. Change of TGT from baseline to 24-months post-implant — Through study completion. Specific time-points: 1, 3, 6, 12, 18, and 24 months post-implant and at the occurrence of any AE Correlation between platelet pro-thrombinase activity and the development of post-implant complications
Number of participants with treatment-related adverse events. Change of clinical and coagulation parameters from baseline to 24-months post-implant — Through study completion. Specific time-points: 1, 3, 6, 12, 18, and 24 months post-implant and at the occurrence of any AE Correlation between coagulation parameters and the development of post-implant complications
Number of participants with treatment-related adverse events. Change of pump working conditions after the device implant — Through study completion. Specific time-points: 1, 3, 6, 12, 18, and 24 months post-implant and at the occurrence of any AE Correlation between pump working conditions and the development of post-implant complications
Trial sites (1)
Facility
City
Region
Status
San Raffaele Scientifc Institute - Cardiothoracic Intensive Care Unit
Milan
MI
Recruiting
More Scientific Institute San Raffaele trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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