Platelet Agregation in Patients on ECMO

May 11, 2023 updated by: Marko Noc, University Medical Centre Ljubljana
An observational study in which investigators will observe platelet inhibition in patients on VA ECMO acorrding to treatment with P2Y12 inhibitor.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Consecutive patents treated with ECMO.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
V-A ECMO without P2Y12 inhibitors
control group
Diagnostic test: P2Y12 Platelet Aggregation Inhibitor
Verify now PRU test
V-A ECMO with P2Y12 inhibitor at the time of ECMO
observational group 1
Diagnostic test: P2Y12 Platelet Aggregation Inhibitor
Verify now PRU test
V-A ECMO already recieving P2Y12 inhibitors
observational group 2
Diagnostic test: P2Y12 Platelet Aggregation Inhibitor
Verify now PRU test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Verify now P2Y12 platelet inhibition
Time Frame: (Time Frame: Hour 2 after VA ECMO insertion)
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
Time Frame: (Time Frame: Hour 4 after VA ECMO insertion)
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
Time Frame: (Time Frame: Hour 12 after VA ECMO insertion)
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
Time Frame: (Time Frame: Hour 22 after VA ECMO insertion)
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
Time Frame: (Time Frame: Hour 48 after VA ECMO insertion)
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
Time Frame: (Time Frame: Hour 72 after VA ECMO insertion)
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
Time Frame: (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.
(Time Frame: Hour 24 after VA ECMO removal)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Centre Ljubljana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2019

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

September 1, 2022

First Submitted That Met QC Criteria

September 13, 2022

First Posted (Actual)

September 15, 2022

Study Record Updates

Last Update Posted (Actual)

May 12, 2023

Last Update Submitted That Met QC Criteria

May 11, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KOIIM-UM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

If needed we are happy to share data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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