Platelet Agregation in Patients on ECMO

Study Overview
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Brief Summary
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An observational study in which investigators will observe platelet inhibition in patients on VA ECMO acorrding to treatment with P2Y12 inhibitor.

Detailed Description
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Investigators will perform an observational study in which platelet inhibition in patients on VA ECMO acorrding to treatment with P2Y12 inhibitor will be observed. Participants will be divided into three groups: A: patients on V-A ECMO without P2Y12 inhibitors B patients on V-A ECMO with P2Y12 inhibitors with administration of P2Y12 inhibitor at the time of ECMO insertion C: patients on V-A ECMO already recieving P2Y12 inhibitors at the time of ECMO insertion. Blood samples will be taken prior to and at 2, 4, 12, 22, 48, 72 after ECMO insertion and after removal of an ECMO. VerifyNow System will be used to measure platelet agregation (PRU test).

Official Title
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Platelet Agregation in Patients on ECMO

Conditions
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Platelet Refractoriness

Intervention / Treatment
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* Diagnostic Test: P2Y12 Platelet Aggregation Inhibitor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all patients on VA ECMO Exclusion Criteria: known P2Y12 alergy thrombocitopenic patents (< 50*109/L), patients treated with eptifibatide ali bivalirudin patients younger than 18 years pregnant patients

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| V-A ECMO without P2Y12 inhibitors<br>control group | Diagnostic Test: P2Y12 Platelet Aggregation Inhibitor<br>* Verify now PRU test<br>|
| V-A ECMO with P2Y12 inhibitor at the time of ECMO<br>observational group 1 | Diagnostic Test: P2Y12 Platelet Aggregation Inhibitor<br>* Verify now PRU test<br>|
| V-A ECMO already recieving P2Y12 inhibitors<br>observational group 2 | Diagnostic Test: P2Y12 Platelet Aggregation Inhibitor<br>* Verify now PRU test<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Verify now P2Y12 platelet inhibition | Platelet inhibition measured by VerifyNow as P2Y12 reaction units (PRU). Platelet reactivity reflects P2Y12 inhibitor effect with higher PRU values showing low P2Y12 response and lower values decreased platelet reactivity due to the effect of a P2Y12 inhibitor. | (Time Frame: Hour 2 after VA ECMO insertion) | 
| Verify now P2Y12 platelet inhibition | Platelet inhibition measured by VerifyNow as P2Y12 reaction units (PRU). Platelet reactivity reflects P2Y12 inhibitor effect with higher PRU values showing low P2Y12 response and lower values decreased platelet reactivity due to the effect of a P2Y12 inhibitor. | (Time Frame: Hour 4 after VA ECMO insertion) | 
| Verify now P2Y12 platelet inhibition | Platelet inhibition measured by VerifyNow as P2Y12 reaction units (PRU). Platelet reactivity reflects P2Y12 inhibitor effect with higher PRU values showing low P2Y12 response and lower values decreased platelet reactivity due to the effect of a P2Y12 inhibitor. | (Time Frame: Hour 12 after VA ECMO insertion) | 
| Verify now P2Y12 platelet inhibition | Platelet inhibition measured by VerifyNow as P2Y12 reaction units (PRU). Platelet reactivity reflects P2Y12 inhibitor effect with higher PRU values showing low P2Y12 response and lower values decreased platelet reactivity due to the effect of a P2Y12 inhibitor. | (Time Frame: Hour 22 after VA ECMO insertion) | 
| Verify now P2Y12 platelet inhibition | Platelet inhibition measured by VerifyNow as P2Y12 reaction units (PRU). Platelet reactivity reflects P2Y12 inhibitor effect with higher PRU values showing low P2Y12 response and lower values decreased platelet reactivity due to the effect of a P2Y12 inhibitor. | (Time Frame: Hour 48 after VA ECMO insertion) | 
| Verify now P2Y12 platelet inhibition | Platelet inhibition measured by VerifyNow as P2Y12 reaction units (PRU). Platelet reactivity reflects P2Y12 inhibitor effect with higher PRU values showing low P2Y12 response and lower values decreased platelet reactivity due to the effect of a P2Y12 inhibitor. | (Time Frame: Hour 72 after VA ECMO insertion) | 
| Verify now P2Y12 platelet inhibition | Platelet inhibition measured by VerifyNow as P2Y12 reaction units (PRU). Platelet reactivity reflects P2Y12 inhibitor effect with higher PRU values showing low P2Y12 response and lower values decreased platelet reactivity due to the effect of a P2Y12 inhibitor. | (Time Frame: Hour 24 after VA ECMO removal) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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V-A ECMO, platelet reactivity, ECMO