Implantation of a Veno-arterial or Veno-venous ECMOECMOstaseNCT03832842
Thrombin Generation as a New Test for Anticoagulation Management in Patients With ECMO
An observational study of Implantation of a Veno-arterial or Veno-venous ECMO, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
ECMO (Extracorporeal Membrane Oxygenation) is a circulatory assistance device aiming at maintaining or restoring cardiopulmonary circulation. Complications of this device are mainly hemorrhagic, related to coagulopathy induced by the initial pathology or by the device itself, or thrombotic and ischemic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Implantation of a Veno-arterial or Veno-venous ECMO
- What is being tested?
- Blood sample
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 16 May 2019to 1 Feb 2021
- 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: Implantation of a veno-arterial or veno-venous ECMO during hospitalization in intensive care unit
Who may be able to join
- Male or female age ≥ 18 years old
- Implantation of a veno-arterial or veno-venous ECMO during hospitalization in intensive care
- Informed consent
Who cannot join
- Patient on veno-arterial ECMO after cardiac, cardiopulmonary surgery or after insertion of a left or biventricular cardiac assist device
- Contraindication to curative anticoagulation
- Congenital hemostasis disorder or anatomical abnormality predisposing to hemorrhage (hemophilia, constitutional thrombocytopathies, Willebrand disease, hereditary hemorrhagic telangiectasia, etc.)
- History of heparin-induced thrombocytopenia
- Moribund patient at the day of inclusion
- Do Not Resuscitate decision
Show all 10Show fewer
- Subject under the protection of justice
- Subject under guardianship or curatorship
- Pregnancy
- Breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
ECMO (Extracorporeal Membrane Oxygenation) is a circulatory assistance device aiming at maintaining or restoring cardiopulmonary circulation. Complications of this device are mainly hemorrhagic, related to coagulopathy induced by the initial pathology or by the device itself, or thrombotic and ischemic. One of the major challenges is therefore the management of a suitable curative anticoagulation, sufficient to limit the activation of hemostasis du to the ECMO, but reasonable to prevent hemorrhagic complications. To date, there is no standardized and validated protocol for the management of anticoagulation of patients under ECMO. The thrombin generation may be a valuable test to manage anticoagulation of patients with ECMO.
- Being tested
- Blood sample
- Keywords
- ECMO, thrombin generation test, hemostasis, bleeding events, thrombotic events
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleDiagnostic test
Blood sample
What is being measured
The primary outcome is the main question the study is designed to answer.
The endogenous thrombin potential (ETP) will be measured.
Measured: prior to ECMO placement at Hours 0 (ECMO circulation)
The endogenous thrombin potential (ETP) will be measured.
Measured: Hours 12
The endogenous thrombin potential (ETP) will be measured.
Measured: daily from Day1 to Day10 and at each dosing of anti-Xa.
Secondary outcomes (14)
Levels of hemostasis parameters:
thrombin generation test
Measured: daily from Day1 to Day10
Levels of hemostasis parameters:
platelets
Measured: daily from Day1 to Day10
Levels of hemostasis parameters:
anti-Xa
Measured: daily from Day1 to Day10
Levels of hemostasis parameters:
aPTT
Measured: daily from Day1 to Day10
Levels of hemostasis parameters:
prothrombin time
Measured: daily from Day1 to Day10
Levels of hemostasis parameters:
fibrinogen
Measured: daily from Day1 to Day10
Levels of hemostasis parameters:
factor V
Measured: daily from Day1 to Day10
Levels of hemostasis parameters:
D-dimers
Measured: daily from Day1 to Day10
Levels of hemostasis parameters:
antithrombin
Measured: daily from Day1 to Day10
Levels of markers of vascular cell activation
microvesicles
Measured: daily from Day1 to Day10
Levels of markers of vascular cell activation
neutrophil extra-cellular traps
Measured: daily from Day1 to Day10
Incidence of bleeding events defined by the WHO classification,
type of bleeding (venous or arterial), blood/platelet/plasma transfusion (number, volume), fibrinogen treatment, calcium treatment, therapeutic intervention (surgical/radiological/endoscopic/manual)
Measured: daily from Day1 to Day10
Incidence of thrombotic and ischemic events: ischemic stroke, limb ischemia, myocardial infarction, ECMO thrombosis
Measured: daily from Day1 to Day10
Mortality: number of patients who are dead by day 28
Measured: day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study start16 May 2019
- Primary completion4 Dec 2020
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implantation of a Veno-arterial or Veno-venous ECMOStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julie HELMS, MD, PhD, Principal investigator, University Hospital, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03832842
- Sponsor's protocol ID
- 7251
- Acronym
- ECMOstase
- Status last verified
- Feb 2021
- First submitted
- 23 Jan 2019
- Last updated
- 4 Feb 2021
- 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 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thrombin Generation as a New Test for Anticoagulation Management in Patients With ECMO
- ClinicalTrials.gov ID
- NCT03832842
- Acronym / sponsor ID
- ECMOstase / 7251
- Keywords
- ECMO, thrombin generation test, hemostasis, bleeding events, thrombotic events
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 16 May 2019 (actual)
- Primary completion
- 4 Dec 2020 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 6 Feb 2019 (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 circulatory assistance device aiming at maintaining or restoring cardiopulmonary circulation. Complications of this device are mainly hemorrhagic, related to coagulopathy induced by the initial pathology or by the device itself, or thrombotic and ischemic. One of the major challenges is therefore the management of a suitable curative anticoagulation, sufficient to limit the activation of hemostasis du to the ECMO, but reasonable to prevent hemorrhagic complications. To date, there is no standardized and validated protocol for the management of anticoagulation of patients under ECMO. The thrombin generation may be a valuable test to manage anticoagulation of patients with ECMO.
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
- Implantation of a veno-arterial or veno-venous ECMO during hospitalization in intensive care unit
Key inclusion criteria (3 listed)
- Male or female age ≥ 18 years old
- Implantation of a veno-arterial or veno-venous ECMO during hospitalization in intensive care
- Informed consent
Key exclusion criteria (10 listed)
- Patient on veno-arterial ECMO after cardiac, cardiopulmonary surgery or after insertion of a left or biventricular cardiac assist device
- Contraindication to curative anticoagulation
- Congenital hemostasis disorder or anatomical abnormality predisposing to hemorrhage (hemophilia, constitutional thrombocytopathies, Willebrand disease, hereditary hemorrhagic telangiectasia, etc.)
- History of heparin-induced thrombocytopenia
- Moribund patient at the day of inclusion
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 sampleBlood sample | Diagnostic test | – |
Primary outcome
The endogenous thrombin potential (ETP) will be measured.
Time frame: prior to ECMO placement at Hours 0 (ECMO circulation)
The endogenous thrombin potential (ETP) will be measured.
Time frame: Hours 12
The endogenous thrombin potential (ETP) will be measured.
Time frame: daily from Day1 to Day10 and at each dosing of anti-Xa.
14 secondary outcomes
Levels of hemostasis parameters:
Time frame: daily from Day1 to Day10
Levels of hemostasis parameters:
Time frame: daily from Day1 to Day10
Levels of hemostasis parameters:
Time frame: daily from Day1 to Day10
Levels of hemostasis parameters:
Time frame: daily from Day1 to Day10
Levels of hemostasis parameters:
Time frame: daily from Day1 to Day10
Levels of hemostasis parameters:
Time frame: daily from Day1 to Day10
Levels of hemostasis parameters:
Time frame: daily from Day1 to Day10
Levels of hemostasis parameters:
Time frame: daily from Day1 to Day10
Levels of hemostasis parameters:
Time frame: daily from Day1 to Day10
Levels of markers of vascular cell activation
Time frame: daily from Day1 to Day10
Levels of markers of vascular cell activation
Time frame: daily from Day1 to Day10
Incidence of bleeding events defined by the WHO classification,
Time frame: daily from Day1 to Day10
Incidence of thrombotic and ischemic events: ischemic stroke, limb ischemia, myocardial infarction, ECMO thrombosis
Time frame: daily from Day1 to Day10
Mortality: number of patients who are dead by day 28
Time frame: day 28
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 4 Feb 2021.
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.
Julie HELMS, MD, PhD principal investigator
University Hospital, Strasbourg, France
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 Implantation of a Veno-arterial or Veno-venous ECMO, 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 3 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: finished, as of the sponsor's last update on 4 Feb 2021. 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?
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?
The endogenous thrombin potential (ETP) will be measured. (time frame: prior to ECMO placement at Hours 0 (ECMO circulation)). The study lists 3 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 4 Feb 2021.