Extracorporeal Membrane Oxygenation ComplicationPLAT-VV-ECMONCT07580469
Platelets and Extracorporeal Membrane Oxygenation Veno-venous
An observational study of Extracorporeal Membrane Oxygenation Complication and Hemorrhage, run by University Hospital, Toulouse at 1 site in France.
Trial summary
In severe lung or heart disease, ExtraCorporeal Membrane Oxygenation (ECMO) may be used temporarily and can be responsible for major haemorrhagic complications. Thrombocytopenia and possibly thrombopathy promote bleeding. The primary objective is to characterize platelet dysfunction by aggregometry tests over time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extracorporeal Membrane Oxygenation Complication, Hemorrhage, Blood Platelet Disorder
- What is being tested?
- blood draws
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2026to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: The study population will be selected from adult patients requiring venovenous ECMO support and admitted to the general intensive care unit of Hôpital Rangueil (Toulouse University Hospital), a regional referral center for ECMO in Occitanie West. Patients may be transferred from other hospitals in the region or directly managed at Hôpital Rangueil following ECMO implantation.
Who may be able to join
- Adults aged ≥ 18 years
- No objection to participation in the study, obtained from a relative or trusted person; if no relative is available, inclusion under emergency procedure (pending patient or relative non-opposition)
- Patients requiring admission to the general intensive care unit of Hôpital Rangueil for venovenous ECMO
- Equipped with an arterial catheter for blood sampling
- Ability to undergo the 4 blood draws relevant to the study
- Receiving therapeutic anticoagulation with unfractionated heparin
- Enrolled in a social security program or equivalent
- No measures for Limitation and Withdrawal of Therapy have been implemented
Who cannot join
- Minors
- Patients under court-appointed guardianship or conservatorship
- Pregnant or breastfeeding women
- Hematological disease (leukemia, lymphoma) or constitutional thrombocytopenia
- Platelet transfusion within 7 days prior to enrollment
- Indication for immediate emergency ECMO preventing blood sampling before placement
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- Post-cardiotomy
- Patient on antiplatelet therapy
- Severe thrombocytopenia <50 G/L
- Other invasive mechanical support such as Impella®, intra-aortic balloon pump, or Left Ventricular Assist Device (LVAD)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Study of PLATelet Functions and Risk Factors for Hemorrhagic Complications in Patients on Extracorporeal Membrane Oxygenation Veno-venous: Prospective Monocentric Cohort
In severe lung or heart disease, ExtraCorporeal Membrane Oxygenation (ECMO) may be used temporarily and can be responsible for major haemorrhagic complications. Thrombocytopenia and possibly thrombopathy promote bleeding. The primary objective is to characterize platelet dysfunction by aggregometry tests over time. Secondarily, investigators seek a correlation between haemorrhagic complications at day 10 and markers of platelet action and dysfunction; also, with the level of anticoagulation and inflammation by biomarkers.
Read the detailed description
Despite the frequency of thrombocytopenia in patients on VV-ECMO and its associated haemorrhagic consequences, its predictive factors are still poorly described. Furthermore, studies suggest the presence of thrombopathy in patients on ECMO, but they are scarce and based on a heterogeneous population with a small sample size, or with vent-arterial (VA) ECMO, mainly after cardiac surgery exposed to a different extracorporeal circulation. The factors responsible for this thrombopathy and its repercussions are currently unknown. In contrast to previous studies that focused on platelet functions in patients on ECMO, our study will be the first to analyse specialized platelet functions and thrombo-inflammation in a cohort only with VV-ECMO excluding cardiac surgery patients at risk of thrombopathy. This work will provide, for the first time, a comprehensive view of the patient on VV-ECMO, ranging from clinical characteristics to the study of platelet activation and functions and thrombo-inflammation analysis and also integrating biological data and ECMO characteristics, all over time. The procedure will involve collecting blood samples from the patient on VV-ECMO and platelet aggregation tests will be performed, along with measurements of platelet activation markers and a search for leuko-platelet aggregates. Investigators will evaluate the clinical-biological impact by searching for blood hemolysis, the level of inflammation, coagulopathy and hemorrhagic complications during VV-ECMO support. The patient's clinical characteristics will be analysed until their discharge from the intensive care unit. Clinical, biological, ECMO, and specialized haemostasis data will be studied to achieve the study objectives.
- Conditions
- Extracorporeal Membrane Oxygenation Complication, Hemorrhage, Blood Platelet Disorder, Thrombosis
- Being tested
- blood draws
- Keywords
- VV-ECMO, Platelets, Thrombopathy, thrombo-haemorrhagic complications, thrombo-inflammation
- Medical subject headings
- Hemorrhage, Blood Platelet Disorders, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood drawsOther
Part of the biology data is used from the patient's routine blood tests. Additional blood samples are taken from an arterial catheter already in place. They are performed over 4 periods: one just before start ECMO and 3 under ECMO at 3-day intervals
| Study group | Role | What they receive |
|---|---|---|
| patients on Extracorporeal Membrane Oxygenation veno-venous | major patients admitted to the general intensive care unit on Extracorporeal Membrane Oxygenation veno-venous Receives: Other: blood draws |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet aggregation response over time during venovenous ECMO at baseline
Platelet aggregation level (expressed as percentage intensity) during venovenous ECMO following stimulation with three platelet agonists (TRAP, CRP, and ADP).
Measured: T0: Baseline (before ECMO initiation)
Platelet aggregation response over time during venovenous ECMO at Day 2 of ECMO
Platelet aggregation level (expressed as percentage intensity) during venovenous ECMO following stimulation with three platelet agonists (TRAP, CRP, and ADP).
Measured: T1: Day 2 of ECMO
Platelet aggregation response over time during venovenous ECMO at Day 5 of ECMO
Platelet aggregation level (expressed as percentage intensity) during venovenous ECMO following stimulation with three platelet agonists (TRAP, CRP, and ADP).
Measured: T2: Day 5 of ECMO
Platelet aggregation response over time during venovenous ECMO at Day 8 of ECMO
Platelet aggregation level (expressed as percentage intensity) during venovenous ECMO following stimulation with three platelet agonists (TRAP, CRP, and ADP).
Measured: T3: Day 8 of ECMO
Secondary outcomes (11)
Number of bleeding event
Numbers of Bleeding event occurring within the first 10 days of VV-ECMO: internal and/or external bleeding that, due to its severity, requires discontinuation of anticoagulation and/or a blood transfusion and/or a surgical or interventional procedure and/or results in a life-threatening condition
Measured: Up to Day 10 of ECMO
Platelet activation marker
Concentrations of platelet activation markers
Measured: day 8
Platelet aggregation intensity
Percentage of platelet aggregation intensity measured at the four sampling time points and following stimulation with three platelet agonists (TRAP, CRP, and ADP)
Measured: day 8
Leukocyte-platelet aggregate percentage
Percentage of leukocyte-platelet aggregates with leukocyte and platelet fluorescent labeling (flow cytometry)
Measured: day 8
Systemic anticoagulation level (anti-Xa activity)
The level of systemic anticoagulation will be assessed by anti-Xa activity (IU/mL)
Measured: day 8
Markers of inflammation-leukocyte
Serum concentrations of inflammatory markers including leukocyte count (/mm³)
Measured: day 8
Markers of inflammation- CRP
Serum concentrations of inflammatory markers including C-reactive protein (CRP, mg/L)
Measured: day 8
Markers of inflammation_fibrinogen
Serum concentrations of inflammatory markers including fibrinogen (g/L)
Measured: day 8
Platelet activation and aggregation parameters
Platelet activation marker concentrations and platelet aggregation intensity percentage, including platelet-leukocyte aggregation percentage
Measured: Day 8
Hemolysis parameters-LDH
Serum levels of lactate dehydrogenase (LDH, IU/L)
Measured: day 8
Hemolysis parameters-free bilirubin
Serum levels of and free bilirubin (µmol/L)
Measured: day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study startSep 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extracorporeal Membrane Oxygenation ComplicationStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07580469
- Sponsor's protocol ID
- RC31/25/0617
- Acronym
- PLAT-VV-ECMO
- Status last verified
- Jun 2026
- First submitted
- 27 Apr 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of PLATelet Functions and Risk Factors for Hemorrhagic Complications in Patients on Extracorporeal Membrane Oxygenation Veno-venous: Prospective Monocentric Cohort
- ClinicalTrials.gov ID
- NCT07580469
- Acronym / sponsor ID
- PLAT-VV-ECMO / RC31/25/0617
- Conditions
- Extracorporeal Membrane Oxygenation Complication, Hemorrhage, Blood Platelet Disorder, Thrombosis
- Keywords
- VV-ECMO, Platelets, Thrombopathy, thrombo-haemorrhagic complications, thrombo-inflammation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 12 May 2026 (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.
In severe lung or heart disease, ExtraCorporeal Membrane Oxygenation (ECMO) may be used temporarily and can be responsible for major haemorrhagic complications. Thrombocytopenia and possibly thrombopathy promote bleeding. The primary objective is to characterize platelet dysfunction by aggregometry tests over time. Secondarily, investigators seek a correlation between haemorrhagic complications at day 10 and markers of platelet action and dysfunction; also, with the level of anticoagulation and inflammation by biomarkers.
Detailed description
Despite the frequency of thrombocytopenia in patients on VV-ECMO and its associated haemorrhagic consequences, its predictive factors are still poorly described. Furthermore, studies suggest the presence of thrombopathy in patients on ECMO, but they are scarce and based on a heterogeneous population with a small sample size, or with vent-arterial (VA) ECMO, mainly after cardiac surgery exposed to a different extracorporeal circulation. The factors responsible for this thrombopathy and its repercussions are currently unknown. In contrast to previous studies that focused on platelet functions in patients on ECMO, our study will be the first to analyse specialized platelet functions and thrombo-inflammation in a cohort only with VV-ECMO excluding cardiac surgery patients at risk of thrombopathy. This work will provide, for the first time, a comprehensive view of the patient on VV-ECMO, ranging from clinical characteristics to the study of platelet activation and functions and thrombo-inflammation analysis and also integrating biological data and ECMO characteristics, all over time. The procedure will involve collecting blood samples from the patient on VV-ECMO and platelet aggregation tests will be performed, along with measurements of platelet activation markers and a search for leuko-platelet aggregates. Investigators will evaluate the clinical-biological impact by searching for blood hemolysis, the level of inflammation, coagulopathy and hemorrhagic complications during VV-ECMO support. The patient's clinical characteristics will be analysed until their discharge from the intensive care unit. Clinical, biological, ECMO, and specialized haemostasis data will be studied to achieve the study objectives.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients on Extracorporeal Membrane Oxygenation veno-venous | – | Other: blood drawsmajor patients admitted to the general intensive care unit on Extracorporeal Membrane Oxygenation veno-venous |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be selected from adult patients requiring venovenous ECMO support and admitted to the general intensive care unit of Hôpital Rangueil (Toulouse University Hospital), a regional referral center for ECMO in Occitanie West. Patients may be transferred from other hospitals in the region or directly managed at Hôpital Rangueil following ECMO implantation.
Key inclusion criteria (8 listed)
- Adults aged ≥ 18 years
- No objection to participation in the study, obtained from a relative or trusted person; if no relative is available, inclusion under emergency procedure (pending patient or relative non-opposition)
- Patients requiring admission to the general intensive care unit of Hôpital Rangueil for venovenous ECMO
- Equipped with an arterial catheter for blood sampling
- Ability to undergo the 4 blood draws relevant to the study
Key exclusion criteria (10 listed)
- Minors
- Patients under court-appointed guardianship or conservatorship
- Pregnant or breastfeeding women
- Hematological disease (leukemia, lymphoma) or constitutional thrombocytopenia
- Platelet transfusion within 7 days prior to enrollment
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 |
|---|---|---|
| blood drawsPart of the biology data is used from the patient's routine blood tests. Additional blood samples are taken from an arterial catheter already in place. They are performed over 4 periods: one just before start ECMO and 3 under ECMO at 3-day intervals | Other | patients on Extracorporeal Membrane Oxygenation veno-venous |
Primary outcome
Platelet aggregation response over time during venovenous ECMO at baseline
Time frame: T0: Baseline (before ECMO initiation)
Platelet aggregation level (expressed as percentage intensity) during venovenous ECMO following stimulation with three platelet agonists (TRAP, CRP, and ADP).
Platelet aggregation response over time during venovenous ECMO at Day 2 of ECMO
Time frame: T1: Day 2 of ECMO
Platelet aggregation level (expressed as percentage intensity) during venovenous ECMO following stimulation with three platelet agonists (TRAP, CRP, and ADP).
Platelet aggregation response over time during venovenous ECMO at Day 5 of ECMO
Time frame: T2: Day 5 of ECMO
Platelet aggregation level (expressed as percentage intensity) during venovenous ECMO following stimulation with three platelet agonists (TRAP, CRP, and ADP).
Platelet aggregation response over time during venovenous ECMO at Day 8 of ECMO
Time frame: T3: Day 8 of ECMO
Platelet aggregation level (expressed as percentage intensity) during venovenous ECMO following stimulation with three platelet agonists (TRAP, CRP, and ADP).
11 secondary outcomes
Number of bleeding event
Time frame: Up to Day 10 of ECMO
Platelet activation marker
Time frame: day 8
Platelet aggregation intensity
Time frame: day 8
Leukocyte-platelet aggregate percentage
Time frame: day 8
Systemic anticoagulation level (anti-Xa activity)
Time frame: day 8
Markers of inflammation-leukocyte
Time frame: day 8
Markers of inflammation- CRP
Time frame: day 8
Markers of inflammation_fibrinogen
Time frame: day 8
Platelet activation and aggregation parameters
Time frame: Day 8
Hemolysis parameters-LDH
Time frame: day 8
Hemolysis parameters-free bilirubin
Time frame: day 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
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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.
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 Extracorporeal Membrane Oxygenation Complication and Hemorrhage, run by University Hospital, Toulouse at 1 site in France.
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 8 inclusion and 10 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: opening soon, as of the sponsor's last update on 29 Jun 2026. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Baptiste COMPAGNON (5 61 32 27 99 ext. +33, compagnon.b@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelet aggregation response over time during venovenous ECMO at baseline (time frame: T0: Baseline (before ECMO initiation)). The study lists 4 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 29 Jun 2026.