Patients With ECMOECMO PFA-100NCT03248596
Interest in Evaluating Primary Hemostasis in Patients With Veno-venous Extracorporeal Membrane Oxygenation (ECMO)
An observational study of Patients With ECMO, run by Rennes University Hospital at 1 site in France.
Trial summary
The aim of the study is a better understanding of hemorrhagic events causes in patients with ECMO, prevent them and decrease the number of transfusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With ECMO
- How many people
- 5 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2016to Jul 2016
- 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 ECMO
Who may be able to join
- Patient older than 18 years old
- Patient with ECMO
- Patient hospitalized in an intensive care unit at the University Hospital of Rennes
Who cannot join
- Known history for constitutional pathology of the primary haemostasis
- Platelets < 100000 / mm3 or hematocrit < 28 % between H+12 and H+24
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is a better understanding of hemorrhagic events causes in patients with ECMO, prevent them and decrease the number of transfusion.
Read the detailed description
The most frequent complication during ECMO is hemorrhage especially as a curative anticoagulant treatment is necessary. The primary hemostasis is also affected with a von Willebrand disease and thrombopathy, well known but not studied by recent tests.The identification of primary haemostasis deficits with these tools would allow to supply them and decrease the morbi-mortality related to the transfusion.
- Conditions
- Patients With ECMO
- Keywords
- Extracorporeal Membrane Oxygenation (ECMO), Primary hemostasis
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate primary hemostasis in patient with ECMO at University Hospital of Rennes
Measured: Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2017
- Study startFeb 2016
- Primary completionJul 2016
- Study completionJul 2016
Why it stopped: Obsolete study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With ECMOStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 5 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
- NCT03248596
- Sponsor's protocol ID
- 35RC15_3023_ECMO PFA-100
- Acronym
- ECMO PFA-100
- Status last verified
- Nov 2017
- First submitted
- 9 Aug 2017
- Last updated
- 21 Nov 2017
- 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 21 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest in Evaluating Primary Hemostasis in Patients With Veno-venous Extracorporeal Membrane Oxygenation (ECMO)
- ClinicalTrials.gov ID
- NCT03248596
- Acronym / sponsor ID
- ECMO PFA-100 / 35RC15_3023_ECMO PFA-100
- Conditions
- Patients With ECMO
- Keywords
- Extracorporeal Membrane Oxygenation (ECMO), Primary hemostasis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Obsolete study
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 14 Aug 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 aim of the study is a better understanding of hemorrhagic events causes in patients with ECMO, prevent them and decrease the number of transfusion.
Detailed description
The most frequent complication during ECMO is hemorrhage especially as a curative anticoagulant treatment is necessary. The primary hemostasis is also affected with a von Willebrand disease and thrombopathy, well known but not studied by recent tests.The identification of primary haemostasis deficits with these tools would allow to supply them and decrease the morbi-mortality related to the transfusion.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with ECMO
Key inclusion criteria (3 listed)
- Patient older than 18 years old
- Patient with ECMO
- Patient hospitalized in an intensive care unit at the University Hospital of Rennes
Key exclusion criteria (2 listed)
- Known history for constitutional pathology of the primary haemostasis
- Platelets < 100000 / mm3 or hematocrit < 28 % between H+12 and H+24
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
Evaluate primary hemostasis in patient with ECMO at University Hospital of Rennes
Time frame: Day 5
Results and safety
The study was stopped early (reason given: Obsolete study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2017.
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Enrolling by invitation
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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 Patients With ECMO, 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 3 inclusion and 2 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: stopped early, as of the sponsor's last update on 21 Nov 2017. 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 was stopped early (reason given: Obsolete study). Results are not available in the source record.
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?
Evaluate primary hemostasis in patient with ECMO at University Hospital of Rennes (time frame: Day 5). 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 21 Nov 2017.