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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V-A ECMO without P2Y12 inhibitors | control group |
| |
| V-A ECMO with P2Y12 inhibitor at the time of ECMO | observational group 1 |
| |
| V-A ECMO already recieving P2Y12 inhibitors | observational group 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| P2Y12 Platelet Aggregation Inhibitor | Diagnostic Test | Verify now PRU test |
|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Consecutive patents treated with ECMO.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marko Noc, MD, phD | Contact | +38641723807 | marko.noc@kclj.si | |
| Ursa Mikuz, MD | Contact | ursa.mikuz@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMC Ljubljana | Recruiting | Ljubljana | 1000 | Slovenia |
If needed we are happy to share data
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| (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) |