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Dynamics of Platelet Activation in Patients With Ventricular Assist Device (VAD)

ConditionsThrombosisBlood Coagulation DisorderPlatelet ThrombusPlatelet Dysfunction Due to AspirinFailure;Ventricular
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorScientific Institute San Raffaele

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial population

Patient with end-stage heart failure receiving a mechanical circulatory support system

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • PAS assay, TGT

    Diagnostic test

    Evaluation of platelet function

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: VAD-implanted patients1 intervention
Group B: VAD-patients suffering adverse events (AE)1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with treatment-related adverse events. Change of PAS assay from baseline to 24 months post-implant

Correlation between platelet activation and the development of post-implant complications

Time frame
Through study completion. Specific time-points: 1, 3, 6, 12, 18, and 24 months post-implant and at the occurrence of any AE
2

Number of participants with treatment-related adverse events. Change of TGT from baseline to 24-months post-implant

Correlation between platelet pro-thrombinase activity and the development of post-implant complications

Time frame
Through study completion. Specific time-points: 1, 3, 6, 12, 18, and 24 months post-implant and at the occurrence of any AE
3

Number of participants with treatment-related adverse events. Change of clinical and coagulation parameters from baseline to 24-months post-implant

Correlation between coagulation parameters and the development of post-implant complications

Time frame
Through study completion. Specific time-points: 1, 3, 6, 12, 18, and 24 months post-implant and at the occurrence of any AE
4

Number of participants with treatment-related adverse events. Change of pump working conditions after the device implant

Correlation between pump working conditions and the development of post-implant complications

Time frame
Through study completion. Specific time-points: 1, 3, 6, 12, 18, and 24 months post-implant and at the occurrence of any AE

Secondary outcomes

1

Number of participants with treatment-related adverse events. Change of prescribed antithrombotic therapy (anticoagulation and antiplatelet drugs) from baseline to 24 months post-implant

Correlation between antithrombotic therapy and the development of post-implant complications

Time frame
Through study completion. Specific time-points: 1, 3, 6, 12, 18, and 24 months post-implant and at the occurrence of any AE

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Scientific Institute San Raffaele

Lead sponsor

Università Vita-Salute San Raffaele

Collaborator

Source ClinicalTrials.gov
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