Platelet Agregation in Patients on ECMO

Platelet Refractoriness Clinical Trial

Official title:

Platelet Agregation in Patients on ECMO

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05542134
• Other study ID #: KOIIM-UM
• Status: Recruiting
• Start date: January 17, 2019
• Est. completion date: June 1, 2023

Study information

• Verified date: May 2023
• Source: University Medical Centre Ljubljana
• Contact: Marko Noc, MD, phD
• Phone: +38641723807
• Email: marko.noc[@]kclj.si
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Platelet Refractoriness

Intervention

Diagnostic Test:
• P2Y12 Platelet Aggregation Inhibitor
Verify now PRU test

Locations

Country	Name	City	State
Slovenia	UMC Ljubljana	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)