Platelet RefractorinessNCT05542134
Platelet Agregation in Patients on ECMO
An observational study of Platelet Refractoriness, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
An observational study in which investigators will observe platelet inhibition in patients on VA ECMO acorrding to treatment with P2Y12 inhibitor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Platelet Refractoriness
- What is being tested?
- P2Y12 Platelet Aggregation Inhibitor
- How many people
- 50 participants
- Where
- 1 siteSlovenia
- Study dates
- 17 Jan 2019to 1 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patents treated with ECMO.
Who may be able to join
- all patients on VA ECMO
Who cannot join
- known P2Y12 alergy
- thrombocitopenic patents (< 50*109/L),
- patients treated with eptifibatide ali bivalirudin
- patients younger than 18 years
- pregnant patients
Trial locations and contacts
1 site in 1 country.
Ursa Mikuz, MD contact
Slovenia1 site, 1 recruiting
- Recruiting
UMC Ljubljana
Ljubljana, 1000
Marko Noc, MD, phD, +38641723807, marko.noc@kclj.si
Ursa Mikuz, MD, ursa.mikuz@gmail.com
About this study
An observational study in which investigators will observe platelet inhibition in patients on VA ECMO acorrding to treatment with P2Y12 inhibitor.
Read the 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).
- Conditions
- Platelet Refractoriness
- Being tested
- P2Y12 Platelet Aggregation Inhibitor
- Keywords
- V-A ECMO, platelet reactivity, ECMO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P2Y12 Platelet Aggregation InhibitorDiagnostic test
Verify now PRU test
| Study group | Role | What they receive |
|---|---|---|
| V-A ECMO without P2Y12 inhibitors | control group Receives: Diagnostic Test: P2Y12 Platelet Aggregation Inhibitor | |
| V-A ECMO with P2Y12 inhibitor at the time of ECMO | observational group 1 Receives: Diagnostic Test: P2Y12 Platelet Aggregation Inhibitor | |
| V-A ECMO already recieving P2Y12 inhibitors | observational group 2 Receives: Diagnostic Test: P2Y12 Platelet Aggregation Inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: (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.
Measured: (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.
Measured: (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.
Measured: (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.
Measured: (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.
Measured: (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.
Measured: (Time Frame: Hour 24 after VA ECMO removal)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start17 Jan 2019
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platelet RefractorinessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marko Noc, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05542134
- Sponsor's protocol ID
- KOIIM-UM
- Status last verified
- May 2023
- First submitted
- 1 Sep 2022
- Last updated
- 12 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If needed we are happy to share data
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Agregation in Patients on ECMO
- ClinicalTrials.gov ID
- NCT05542134
- Acronym / sponsor ID
- KOIIM-UM
- Conditions
- Platelet Refractoriness
- Keywords
- V-A ECMO, platelet reactivity, ECMO
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 17 Jan 2019 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 15 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| V-A ECMO without P2Y12 inhibitors | – | Diagnostic Test: P2Y12 Platelet Aggregation Inhibitorcontrol group |
| V-A ECMO with P2Y12 inhibitor at the time of ECMO | – | Diagnostic Test: P2Y12 Platelet Aggregation Inhibitorobservational group 1 |
| V-A ECMO already recieving P2Y12 inhibitors | – | Diagnostic Test: P2Y12 Platelet Aggregation Inhibitorobservational group 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patents treated with ECMO.
Key inclusion criteria (1 listed)
- all patients on VA ECMO
Key exclusion criteria (5 listed)
- known P2Y12 alergy
- thrombocitopenic patents (< 50*109/L),
- patients treated with eptifibatide ali bivalirudin
- patients younger than 18 years
- pregnant patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| P2Y12 Platelet Aggregation InhibitorVerify now PRU test | Diagnostic test | V-A ECMO already recieving P2Y12 inhibitors, V-A ECMO with P2Y12 inhibitor at the time of ECMO, V-A ECMO without P2Y12 inhibitors |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Individual participant dataSharing planned: Undecided. If needed we are happy to share data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ursa Mikuz, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Platelet Refractoriness, run by University Medical Centre Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marko Noc, MD, phD (+38641723807, marko.noc@kclj.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Verify now P2Y12 platelet inhibition (time frame: (Time Frame: Hour 2 after VA ECMO insertion)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2023.