Platelet Agregation in Patients on ECMO

Recruiting

• Conditions: Platelet Refractoriness
• Interventions: Diagnostic Test: P2Y12 Platelet Aggregation Inhibitor

• Registration Number: NCT05542134
• Lead Sponsor: University Medical Centre Ljubljana

Brief Summary

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

Detailed 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).

Study Timeline

• Study Start: 2019-01-17
• Study First Submitted: 2022-09-01
• Study First Submitted QC: 2022-09-13
• Study First Posted: 2022-09-15
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-11
• Last Update Posted: 2023-05-12
• Primary Completion: 2023-06-01
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
V-A ECMO already recieving P2Y12 inhibitors	P2Y12 Platelet Aggregation Inhibitor	observational group 2
V-A ECMO with P2Y12 inhibitor at the time of ECMO	P2Y12 Platelet Aggregation Inhibitor	observational group 1
V-A ECMO without P2Y12 inhibitors	P2Y12 Platelet Aggregation Inhibitor	control group

Primary Outcome Measures

Name	Time	Method
Verify now P2Y12 platelet inhibition	(Time Frame: Hour 24 after VA ECMO removal)	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.

Trial Locations

Locations (1)

UMC Ljubljana; 🇸🇮 Ljubljana, Slovenia