Extracorporeal Membrane OxygenationNCT03355625
Platelet Function During Extracorporeal Membrane Oxygenation in Adult Patients
An observational study of Extracorporeal Membrane Oxygenation and Platelet Activation, run by Aarhus University Hospital at 2 sites in Denmark.
Trial summary
The primary aim is to describe platelet function in adult patients treated with extracorporeal membrane oxygenation (ECMO). A clarification of the platelet function in these critically ill patients contributes to an understanding of the mechanisms underlying their coagulopathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extracorporeal Membrane Oxygenation, Platelet Activation, Platelet Aggregation
- How many people
- 33 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Sep 2017to 30 Nov 2019
- 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: Patients treated with ECMO at the Intensive Care Unit East, Aarhus University Hospital.
Who may be able to join
- Treatment with veno-venous or veno-arterial ECMO
- Age ≥18 years
Who cannot join
- ECMO treatment initiated post-operatively
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Centre of Haemophilia and Thrombosis, Department of Clinical Biochemistry, Aarhus University Hospital
Aarhus, 8000
Department of Anaesthesiology and Intensive Care Unit East, Aarhus University Hospital
Aarhus, 8000
About this study
The primary aim is to describe platelet function in adult patients treated with extracorporeal membrane oxygenation (ECMO). A clarification of the platelet function in these critically ill patients contributes to an understanding of the mechanisms underlying their coagulopathy.
The present study is a substudy to the study entitled; "Coagulopathy During Extracorporeal Membrane Oxygenation" (pending Clinical Trial ID number).
Read the detailed description
The knowledge of platelet function during extracorporeal membrane oxygenation (ECMO) remains sparse. In the present study, the aim is to investigate platelet function in adult patients treated with ECMO using flow cytometry. The investigators hypothesize that platelet function increases from day 1 to day 3 in patients treated with ECMO. The secondary aim is to investigate the association between platelet function and the incidence of bleeding episodes and thrombosis during ECMO treatment.
The present study is a substudy to the study entitled; "Coagulopathy During Extracorporeal Membrane Oxygenation" (pending Clinical Trial ID number).
- Conditions
- Extracorporeal Membrane Oxygenation, Platelet Activation, Platelet Aggregation, Platelet Function Tests, Blood Platelets, Intensive Care Units
- Keywords
- Flow Cytometry, eCPR, Extracorporeal Life Support
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in platelet function
Platelet function on day 3 compared with day 1 on ECMO. Measured by flow cytometry
Measured: Platelet function measured day 1 and day 3 on ECMO
Secondary outcomes (3)
Changes in platelet aggregation
Comparison of platelet aggregation measured by whole blood impedance aggregometry (Multiplate).
Measured: Platelet function measured every morning from day 1 to day 8 on ECMO (except weekends).
Immature platelet count
Estimation of platelet turn-over measured by a blood analyzer (Sysmex)
Measured: Measured every morning from day 1 to day 8 on ECMO (except weekends)
Platelet count
Estimation of platelet count measured by a blood analyzer (Sysmex)
Measured: Measured every morning from day 1 to day 8 on ECMO (except weekends)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2017
- Study start1 Sep 2017
- Primary completion30 Sep 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extracorporeal Membrane OxygenationStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- 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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus
- Responsible party
- Sponsor
- Investigators
- Camilla Mains Balle, Research fellow, Principal investigator, Centre of Haemophilia and Thrombosis, Department of Clinical Biochemistry, Aarhus University HospitalAnne-Mette Hvas, Professor, MD, PhD, Study chair, Centre of Haemophilia and Thrombosis, Department of Clinical Biochemistry, Aarhus University HospitalAnni Nørgaard Jeppesen, MD, PhD, Study chair, Department of Anaesthesiology and Intensive Care Unit East, Aarhus University HospitalSteffen Christensen, MD, PhD, Study chair, Department of Anaesthesiology and Intensive Care Unit East, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03355625
- Sponsor's protocol ID
- ECMO-Camilla
- Status last verified
- May 2022
- First submitted
- 22 Nov 2017
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Function During Extracorporeal Membrane Oxygenation in Adult Patients
- ClinicalTrials.gov ID
- NCT03355625
- Acronym / sponsor ID
- ECMO-Camilla
- Conditions
- Extracorporeal Membrane Oxygenation, Platelet Activation, Platelet Aggregation, Platelet Function Tests, Blood Platelets, Intensive Care Units
- Keywords
- Flow Cytometry, eCPR, Extracorporeal Life Support
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- University of Aarhus
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 28 Nov 2017 (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.
The primary aim is to describe platelet function in adult patients treated with extracorporeal membrane oxygenation (ECMO). A clarification of the platelet function in these critically ill patients contributes to an understanding of the mechanisms underlying their coagulopathy.
The present study is a substudy to the study entitled; "Coagulopathy During Extracorporeal Membrane Oxygenation" (pending Clinical Trial ID number).
Detailed description
The knowledge of platelet function during extracorporeal membrane oxygenation (ECMO) remains sparse. In the present study, the aim is to investigate platelet function in adult patients treated with ECMO using flow cytometry. The investigators hypothesize that platelet function increases from day 1 to day 3 in patients treated with ECMO. The secondary aim is to investigate the association between platelet function and the incidence of bleeding episodes and thrombosis during ECMO treatment.
The present study is a substudy to the study entitled; "Coagulopathy During Extracorporeal Membrane Oxygenation" (pending Clinical Trial ID number).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated with ECMO at the Intensive Care Unit East, Aarhus University Hospital.
Key inclusion criteria (2 listed)
- Treatment with veno-venous or veno-arterial ECMO
- Age ≥18 years
Key exclusion criteria (1 listed)
- ECMO treatment initiated post-operatively
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in platelet function
Time frame: Platelet function measured day 1 and day 3 on ECMO
Platelet function on day 3 compared with day 1 on ECMO. Measured by flow cytometry
3 secondary outcomes
Changes in platelet aggregation
Time frame: Platelet function measured every morning from day 1 to day 8 on ECMO (except weekends).
Immature platelet count
Time frame: Measured every morning from day 1 to day 8 on ECMO (except weekends)
Platelet count
Time frame: Measured every morning from day 1 to day 8 on ECMO (except weekends)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
- Individual participant dataSharing planned: No
Related trials for Extracorporeal Membrane Oxygenation
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Diagnosis of ECMO Cannula Infection: Prospective Comparison of Sampling Methods
ECMO Cannula Infection, Extracorporeal Membrane Oxygenation Complication
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Effect of Transpulmonary MP on Prognosis of Patients With Severe ARDS Treated With VV-ECMO
Acute Respiratory Distress Syndrome, Extracorporeal Membrane Oxygenation
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PACE: Prostacyclin AntiCoagulation in ECMO
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RecruitingObservational study
Pharmacokinetics of Sedatives and Analgesics During Extracorporeal Membrane Oxygenation (ECMO) Support
Drug Effect
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.
Camilla Mains Balle, Research fellow principal investigator
Centre of Haemophilia and Thrombosis, Department of Clinical Biochemistry, Aarhus University Hospital
Anne-Mette Hvas, Professor, MD, PhD study chair
Centre of Haemophilia and Thrombosis, Department of Clinical Biochemistry, Aarhus University Hospital
Anni Nørgaard Jeppesen, MD, PhD study chair
Department of Anaesthesiology and Intensive Care Unit East, Aarhus University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Extracorporeal Membrane Oxygenation and Platelet Activation, run by Aarhus University Hospital at 2 sites in Denmark.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 26 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in platelet function (time frame: Platelet function measured day 1 and day 3 on ECMO). 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 26 May 2022.