NCT05542134

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 17, 2019

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

September 1, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 15, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

May 12, 2023

Status Verified

May 1, 2023

Enrollment Period

4.4 years

First QC Date

September 1, 2022

Last Update Submit

May 11, 2023

Conditions

Platelet Refractoriness

Keywords

V-A ECMOplatelet reactivityECMO

Outcome Measures

Primary Outcomes (7)

  • 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.

    (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)

Study Arms (3)

V-A ECMO without P2Y12 inhibitors

control group

Diagnostic Test: P2Y12 Platelet Aggregation Inhibitor

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

observational group 1

Diagnostic Test: P2Y12 Platelet Aggregation Inhibitor

V-A ECMO already recieving P2Y12 inhibitors

observational group 2

Diagnostic Test: P2Y12 Platelet Aggregation Inhibitor

Interventions

P2Y12 Platelet Aggregation InhibitorDIAGNOSTIC_TEST

Verify now PRU test

V-A ECMO already recieving P2Y12 inhibitorsV-A ECMO with P2Y12 inhibitor at the time of ECMOV-A ECMO without P2Y12 inhibitors

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive patents treated with ECMO.

You may qualify if:

  • all patients on VA ECMO

You may not qualify if:

  • known P2Y12 alergy
  • thrombocitopenic patents (\< 50\*109/L),
  • patients treated with eptifibatide ali bivalirudin
  • patients younger than 18 years
  • pregnant patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMC Ljubljana

Ljubljana, 1000, Slovenia

RECRUITING

Central Study Contacts

Marko Noc, MD, phD

CONTACT

+38641723807marko.noc@kclj.si

Ursa Mikuz, MD

CONTACT

ursa.mikuz@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

September 1, 2022

First Posted

September 15, 2022

Study Start

January 17, 2019

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

May 12, 2023

Record last verified: 2023-05

Locations

SL(1)