Platelet Agregation in Patients on ECMO

NCT ID: NCT05542134

Last Updated: 2023-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-17

Study Completion Date

2023-06-01

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).

Conditions

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Platelet Refractoriness

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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V-A ECMO without P2Y12 inhibitors

control group

P2Y12 Platelet Aggregation Inhibitor

Intervention Type DIAGNOSTIC_TEST

Verify now PRU test

V-A ECMO with P2Y12 inhibitor at the time of ECMO

observational group 1

P2Y12 Platelet Aggregation Inhibitor

Intervention Type DIAGNOSTIC_TEST

Verify now PRU test

V-A ECMO already recieving P2Y12 inhibitors

observational group 2

P2Y12 Platelet Aggregation Inhibitor

Intervention Type DIAGNOSTIC_TEST

Verify now PRU test

Interventions

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P2Y12 Platelet Aggregation Inhibitor

Verify now PRU test

Intervention Type DIAGNOSTIC_TEST

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medical Centre Ljubljana

OTHER

Sponsor Role lead

Responsible Party

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Marko Noc

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UMC Ljubljana

Ljubljana, , Slovenia

Site Status RECRUITING

Countries

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Slovenia

Central Contacts

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Marko Noc, MD, phD

Role: CONTACT

+38641723807

Ursa Mikuz, MD

Role: CONTACT

Facility Contacts

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Marko Noc, MD, phD

Role: primary

+38641723807

Ursa Mikuz, MD

Role: backup

Other Identifiers

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KOIIM-UM

Identifier Type: -

Identifier Source: org_study_id

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