ECMOECMOstase2NCT07039513
EVOLUTION OF D-DIMER AS A MARKER OF BLEEDING RISK ON ECMO
An observational study of ECMO and Mplementation of a Veno-venous VV or Veno-arterial VA, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
ECMO (extracorporeal membrane oxygenation) is a life-saving device, used in intensive care to treat severe respiratory or cardiac failure. However, it carries a high risk of serious life-threatening bleeding. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ECMO, Mplementation of a Veno-venous VV or Veno-arterial VA, INTENSIVE CARE
- What is being tested?
- Blood sampling collection
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 27 Nov 2025to 1 Jun 2027
- 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: Hospitalized patient in intensive care with implementation of a VV or VA ECMO for less than 24 hours
Who may be able to join
- Male or female ≥ 18 years of age
- Hospitalized patient in intensive care
- Implementation of a VV or VA ECMO for less than 24 hours
- Patient affiliated to a social protection health insurance scheme
- Non-opposition by the patient or a relative in the event that the patient is not in a state to express his or her non-opposition or inclusion in an emergency procedure in the event that the patient is not in a state to express his or her non-opposition and no relative of the patient can be reached.
Who cannot join
- Patient on veno-arterial ECMO after cardiac, cardiopulmonary surgery or after placement of a left or biventricular cardiac assist device
- Congenital hemostasis disorder or anatomical abnormality predisposing to bleeding
- Dying patient on the day of inclusion
- Patient under judicial protection
- Patient under guardianship or curatorship
- Pregnancy
- Breastfeeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Service de Médecine Intensive - Réanimation Nouvel Hôpital Civil
Strasbourg, 67098
About this study
ECMO (extracorporeal membrane oxygenation) is a life-saving device, used in intensive care to treat severe respiratory or cardiac failure. However, it carries a high risk of serious life-threatening bleeding.
Bleeding complications have been attributed to coagulopathy triggered either by the underlying pathology or by the extracorporeal circuit itself, as well as excessive or inappropriate anticoagulation initiated to prevent thrombotic complications.
The objective of this cohort is to confirm the interest of the evolution of D-dimers as a prognostic marker of serious bleeding events in patients on veno-venous (VV) or veno-arterial (VA) ECMO, and to determine the threshold.
- Being tested
- Blood sampling collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampling collectionOther
Collection of an additional of 2.7mL citrate tube of blood for a D-dimer dosage.
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the most discriminating 24-hour D-Dimer increase threshold for predicting a serious bleeding event under ECMO within 24 hours of D-Dimer increase
Difference in D-dimer over 24 hours associated with the occurrence of severe bleeding within 24 hours.
Measured: 1 month
Secondary outcomes (7)
To estimate the predictive performance of the 24-hour increase in D-dimer in the occurrence of a serious bleeding event on ECMO within 24 hours.
Sensitivity (Se)
Measured: 1 month
To estimate the predictive performance of the 24-hour increase in D-dimer in the occurrence of a serious bleeding event on ECMO within 24 hours.
Specificity (Spe)
Measured: 1 month
To estimate the predictive performance of the 24-hour increase in D-dimer in the occurrence of a serious bleeding event on ECMO within 24 hours.
Positive Predictive Value (PPV)
Measured: 1 month
To estimate the predictive performance of the 24-hour increase in D-dimer in the occurrence of a serious bleeding event on ECMO within 24 hours.
Negative Predictive Value (NPV)
Measured: 1 month
To estimate the predictive performance of the 24-hour increase in D-dimer in the occurrence of a serious bleeding event on ECMO within 24 hours.
Positive and Negative Likelihood Ratios of 24-Hour D-Dimer Increase
Measured: 1 month
To estimate the incidence of bleeding and thrombotic complications on ECMO on day 10
Occurrence of hemorrhagic complications on ECMO on day 10:
Bleeding events defined by BARC classification, type of bleeding (arterial/venous) and location, transfusions of labile blood products (number/volume/type), other treatments (endoscopy with hemostatic procedure,
Measured: 1 month
To estimate the incidence of bleeding and thrombotic complications on ECMO on day 10
Occurrence of thrombotic complications on ECMO on day 10:
Thrombotic and ischemic events: ischemic stroke, limb/extremity ischemia, acute coronary syndrome, ECMO circuit thrombosis
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start27 Nov 2025 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ECMOStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07039513
- Sponsor's protocol ID
- 9557
- Other IDs
- 2024-A02754-43
- Acronym
- ECMOstase2
- Status last verified
- Nov 2025
- First submitted
- 17 Jun 2025
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVOLUTION OF D-DIMER AS A MARKER OF BLEEDING RISK ON ECMO
- ClinicalTrials.gov ID
- NCT07039513
- Acronym / sponsor ID
- ECMOstase2 / 9557
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 27 Nov 2025 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 26 Jun 2025 (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.
ECMO (extracorporeal membrane oxygenation) is a life-saving device, used in intensive care to treat severe respiratory or cardiac failure. However, it carries a high risk of serious life-threatening bleeding.
Bleeding complications have been attributed to coagulopathy triggered either by the underlying pathology or by the extracorporeal circuit itself, as well as excessive or inappropriate anticoagulation initiated to prevent thrombotic complications.
The objective of this cohort is to confirm the interest of the evolution of D-dimers as a prognostic marker of serious bleeding events in patients on veno-venous (VV) or veno-arterial (VA) ECMO, and to determine the threshold.
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
- Hospitalized patient in intensive care with implementation of a VV or VA ECMO for less than 24 hours
Key inclusion criteria (5 listed)
- Male or female ≥ 18 years of age
- Hospitalized patient in intensive care
- Implementation of a VV or VA ECMO for less than 24 hours
- Patient affiliated to a social protection health insurance scheme
- Non-opposition by the patient or a relative in the event that the patient is not in a state to express his or her non-opposition or inclusion in an emergency procedure in the event that the patient is not in a state to express his or her non-opposition and no relative of the patient can be reached.
Key exclusion criteria (7 listed)
- Patient on veno-arterial ECMO after cardiac, cardiopulmonary surgery or after placement of a left or biventricular cardiac assist device
- Congenital hemostasis disorder or anatomical abnormality predisposing to bleeding
- Dying patient on the day of inclusion
- Patient under judicial protection
- Patient under guardianship or curatorship
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 sampling collectionCollection of an additional of 2.7mL citrate tube of blood for a D-dimer dosage. | Other | – |
Primary outcome
To determine the most discriminating 24-hour D-Dimer increase threshold for predicting a serious bleeding event under ECMO within 24 hours of D-Dimer increase
Time frame: 1 month
Difference in D-dimer over 24 hours associated with the occurrence of severe bleeding within 24 hours.
7 secondary outcomes
To estimate the predictive performance of the 24-hour increase in D-dimer in the occurrence of a serious bleeding event on ECMO within 24 hours.
Time frame: 1 month
To estimate the predictive performance of the 24-hour increase in D-dimer in the occurrence of a serious bleeding event on ECMO within 24 hours.
Time frame: 1 month
To estimate the predictive performance of the 24-hour increase in D-dimer in the occurrence of a serious bleeding event on ECMO within 24 hours.
Time frame: 1 month
To estimate the predictive performance of the 24-hour increase in D-dimer in the occurrence of a serious bleeding event on ECMO within 24 hours.
Time frame: 1 month
To estimate the predictive performance of the 24-hour increase in D-dimer in the occurrence of a serious bleeding event on ECMO within 24 hours.
Time frame: 1 month
To estimate the incidence of bleeding and thrombotic complications on ECMO on day 10
Time frame: 1 month
To estimate the incidence of bleeding and thrombotic complications on ECMO on day 10
Time frame: 1 month
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 1 Dec 2025.
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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 ECMO and Mplementation of a Veno-venous VV or Veno-arterial VA, run by University Hospital, Strasbourg, France 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 5 inclusion and 7 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 1 Dec 2025. 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 Julie HELMS, Professor (+33369551369, julie.helms@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the most discriminating 24-hour D-Dimer increase threshold for predicting a serious bleeding event under ECMO within 24 hours of D-Dimer increase (time frame: 1 month). 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 1 Dec 2025.