Severe Cardiac InsufficiencyATECMONCT04133844
Evaluation of Antithrombin Deficiency in Patients of Intensive Care Unit Placed on Extracorporeal Membrane Oxygenation
An observational study of Severe Cardiac Insufficiency, run by Rennes University Hospital at 1 site in France.
Trial summary
Prospective, monocentric, non-interventional study in patients placed on extracorporeal membrane oxygenation (ECMO) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Cardiac Insufficiency
- What is being tested?
- Blood sample
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 5 May 2020to 18 May 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: Patient with cardiac insifficiency placed on extracorporeal membrane oxygenation (ECMO)
Who may be able to join
- Any ICU patient of receiving veno-arterial extracorporeal membrane oxygenation
- Patients who have not expressed opposition to participate
Who cannot join
- Arterial thrombosis or progressive venous thrombosis
- Contraindication to heparin
- Constitutional deficiency in antithrombin
- Patient refusal
- Minor patient
- Protected major (safeguard justice, trusteeship and guardianship) and persons deprived of liberty
Trial locations and contacts
1 site in 1 country.
About this study
Prospective, monocentric, non-interventional study in patients placed on extracorporeal membrane oxygenation (ECMO)
Read the detailed description
Our hypothesis is that ECMO initiation is responsible for a severe decrease of antithrombin level in a high proportion of patients who develop heparin resistance.
- Conditions
- Severe Cardiac Insufficiency
- Being tested
- Blood sample
- Keywords
- extracorporeal membrane oxygenation
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleBiological
Blood sample collection from a peripheral catheter at ECMO initiation (H0), then 2h, 6h, 12h, 24h and daily from day 2 to day 7 or at ECMO discontinuation
| Study group | Role | What they receive |
|---|---|---|
| Extracorporeal membrane oxygenation | Not described Receives: Biological: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
To study antithrombin level from during the first 24h after ECMO initiation
Blood sample at ECMO initiation (H0), then 2h, 6h, 12h, 24h and daily from day 2 to day 7 or at ECMO discontinuation
Measured: Day 7
Secondary outcomes (6)
To study antithrombin level 24h after initialization of ECMO
Blood sample at 24h
Measured: Hour 24
To study the prevalence of antithrombin (AT) deficiency (≤70%) at each time point (from H0 to day 7)
Blood sample
Measured: Day 7
To study relationship between antithrombin level and heparin resistance
Blood sample
Measured: Day 7
To study relationship between antithrombin level and thrombin generation test
Blood sample
Measured: Day 7
To study clinical factors associated with AT deficiency
Blood sample
Measured: Day 7
To describe clinical evolution of patients according to initial AT level
Blood sample
Measured: Hour 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2019
- Study start5 May 2020
- Primary completion18 May 2021
- Study completion18 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Cardiac InsufficiencyStudies of the same condition, open and under way.
- More trials run by Rennes 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04133844
- Sponsor's protocol ID
- 35RC19_9727_ATECMO
- Acronym
- ATECMO
- Status last verified
- Jun 2021
- First submitted
- 17 Oct 2019
- Last updated
- 4 Jun 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 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Antithrombin Deficiency in Patients of Intensive Care Unit Placed on Extracorporeal Membrane Oxygenation
- ClinicalTrials.gov ID
- NCT04133844
- Acronym / sponsor ID
- ATECMO / 35RC19_9727_ATECMO
- Conditions
- Severe Cardiac Insufficiency
- Keywords
- extracorporeal membrane oxygenation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 5 May 2020 (actual)
- Primary completion
- 18 May 2021 (actual)
- Study completion
- 18 May 2021 (actual)
- First posted
- 21 Oct 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.
Prospective, monocentric, non-interventional study in patients placed on extracorporeal membrane oxygenation (ECMO)
Detailed description
Our hypothesis is that ECMO initiation is responsible for a severe decrease of antithrombin level in a high proportion of patients who develop heparin resistance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Extracorporeal membrane oxygenation | – | Biological: Blood sample |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with cardiac insifficiency placed on extracorporeal membrane oxygenation (ECMO)
Key inclusion criteria (2 listed)
- Any ICU patient of receiving veno-arterial extracorporeal membrane oxygenation
- Patients who have not expressed opposition to participate
Key exclusion criteria (6 listed)
- Arterial thrombosis or progressive venous thrombosis
- Contraindication to heparin
- Constitutional deficiency in antithrombin
- Patient refusal
- Minor patient
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 collection from a peripheral catheter at ECMO initiation (H0), then 2h, 6h, 12h, 24h and daily from day 2 to day 7 or at ECMO discontinuation | Biological | Extracorporeal membrane oxygenation |
Primary outcome
To study antithrombin level from during the first 24h after ECMO initiation
Time frame: Day 7
Blood sample at ECMO initiation (H0), then 2h, 6h, 12h, 24h and daily from day 2 to day 7 or at ECMO discontinuation
6 secondary outcomes
To study antithrombin level 24h after initialization of ECMO
Time frame: Hour 24
To study the prevalence of antithrombin (AT) deficiency (≤70%) at each time point (from H0 to day 7)
Time frame: Day 7
To study relationship between antithrombin level and heparin resistance
Time frame: Day 7
To study relationship between antithrombin level and thrombin generation test
Time frame: Day 7
To study clinical factors associated with AT deficiency
Time frame: Day 7
To describe clinical evolution of patients according to initial AT level
Time frame: Hour 0
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 Jun 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Severe Cardiac Insufficiency, run by Rennes University Hospital 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 2 inclusion and 6 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 Jun 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?
To study antithrombin level from during the first 24h after ECMO initiation (time frame: Day 7). 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 Jun 2021.