Veno-arterial Extra-Corporeal Membrane OxygenationNCT04653298
Health-related Quality of Life in Adults After Veno-arterial Extra-Corporeal Membrane Oxygenation Which is a Salvage Therapy Used in Patients With Severe Respiratory or Cardiac Failure Who Have Not Responded to Maximal Conventional Medical Therapy
An observational study of Veno-arterial Extra-Corporeal Membrane Oxygenation and Health Related Quality of Life, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Extracorporeal Membrane Oxygenation (ECMO) is a salvage therapy used in patients with refractory cardiogenic shock. This rescue technique is associated to a high mortality rate and to many complications that can impact the quality of life of the survivors. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Veno-arterial Extra-Corporeal Membrane Oxygenation, Health Related Quality of Life
- What is being tested?
- Evaluation of quality of life, comorbidities and return to work status
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 21 Dec 2020to Dec 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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with veno-arterial ECMO between April 2008 and December 2019 in NHC surgical intensive care of Strasbourg are included in this study. Those patients are retrieved thanks to the Software ICCA.
Who may be able to join
- Adults >18 years
- Veno-arterial ECMO between April 2008 and December 2019 in NHC surgical intensive care of Strasbourg
- Affiliated to the French social security system
Who cannot join
- Patients under guardianship or with legal protection
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Les Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Lina JAZERLI, +33 3 69 55 16 22, lina.jazaerli@chru-strasbourg.fr
Lina JAZERLI
About this study
Official title: Health-related Quality of Life in Adults After Veno-arterial Extra-Corporeal Membrane Oxygenation
Extracorporeal Membrane Oxygenation (ECMO) is a salvage therapy used in patients with refractory cardiogenic shock. This rescue technique is associated to a high mortality rate and to many complications that can impact the quality of life of the survivors. The aim of this study is to evaluate the Health-related quality of life in adults after veino-arterial Extra-Corporeal Membrane Oxygenation. The quality of life will be evaluated thanks to several methods : the Short Form 36, the EQ 5D 5L and the return to work status.
Then, the investigators will analyze by subgroup the quality of life according to the cardiogenic shock etiology and try to determine the risk factors of an altered quality of life. The investigators will also evaluate current comorbidities of the patient thanks to the Groll Index.
- Being tested
- Evaluation of quality of life, comorbidities and return to work status
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of quality of life, comorbidities and return to work statusOther
Quality of life will be evaluated thanks to several methods: Short Form 36, EQ 5D 5L and return to work status Questionnaires will be evaluated through postal and phone call at least 12 months after ECMO.
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of health-related quality of life after veino-arterial ECMO
Quality of life will be evaluated by Short Form 36 ( score 0 to 100)
Measured: The quality of life will be evaluated from 1 to 12 years after the ECMO
Evaluation of health-related quality of life after veino-arterial ECMO
EQ 5D 5L ( description of mobility, personal autonomy, routine activities, pain and discomfort, anxiety and depression and an analog visual scale)
Measured: The quality of life will be evaluated from 1 to 12 years after the ECMO
Secondary outcomes (3)
Analysis by subgroup according to the cardiogenic shock etiology
5 subgroups will be assessed according to the cardiogenic shock etiology: post cardiac surgery, post cardiac ischemia, pulmonary embolism or other right ventricle dysfunction, other etiology
Measured: The quality of life will be evaluated from 1 to 12 years after the ECMO
Research of risk factors of an altered quality of life
5 subgroups will be assessed according to the cardiogenic shock etiology: post cardiac surgery, post cardiac ischemia, pulmonary embolism or other right ventricle dysfunction, other etiology
Measured: The quality of life will be evaluated from 1 to 12 years after the ECMO
Evaluation of the current comorbidities thanks to Groll index
5 subgroups will be assessed according to the cardiogenic shock etiology: post cardiac surgery, post cardiac ischemia, pulmonary embolism or other right ventricle dysfunction, other etiology
Measured: The quality of life will be evaluated from 1 to 12 years after the ECMO
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start21 Dec 2020
- Primary completion21 Dec 2020
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Veno-arterial Extra-Corporeal Membrane OxygenationStudies 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
- 300 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
- NCT04653298
- Sponsor's protocol ID
- 7951
- Status last verified
- Mar 2021
- First submitted
- 28 Sep 2020
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health-related Quality of Life in Adults After Veno-arterial Extra-Corporeal Membrane Oxygenation
- ClinicalTrials.gov ID
- NCT04653298
- Acronym / sponsor ID
- 7951
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 21 Dec 2020 (actual)
- Primary completion
- 21 Dec 2020 (actual)
- Study completion
- Dec 2021 (estimated)
- First posted
- 4 Dec 2020 (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.
Extracorporeal Membrane Oxygenation (ECMO) is a salvage therapy used in patients with refractory cardiogenic shock. This rescue technique is associated to a high mortality rate and to many complications that can impact the quality of life of the survivors. The aim of this study is to evaluate the Health-related quality of life in adults after veino-arterial Extra-Corporeal Membrane Oxygenation. The quality of life will be evaluated thanks to several methods : the Short Form 36, the EQ 5D 5L and the return to work status.
Then, the investigators will analyze by subgroup the quality of life according to the cardiogenic shock etiology and try to determine the risk factors of an altered quality of life. The investigators will also evaluate current comorbidities of the patient thanks to the Groll Index.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with veno-arterial ECMO between April 2008 and December 2019 in NHC surgical intensive care of Strasbourg are included in this study. Those patients are retrieved thanks to the Software ICCA.
Key inclusion criteria (3 listed)
- Adults >18 years
- Veno-arterial ECMO between April 2008 and December 2019 in NHC surgical intensive care of Strasbourg
- Affiliated to the French social security system
Key exclusion criteria (1 listed)
- Patients under guardianship or with legal protection
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 |
|---|---|---|
| Evaluation of quality of life, comorbidities and return to work statusQuality of life will be evaluated thanks to several methods: Short Form 36, EQ 5D 5L and return to work status Questionnaires will be evaluated through postal and phone call at least 12 months after ECMO. | Other | – |
Primary outcome
Evaluation of health-related quality of life after veino-arterial ECMO
Time frame: The quality of life will be evaluated from 1 to 12 years after the ECMO
Quality of life will be evaluated by Short Form 36 ( score 0 to 100)
Evaluation of health-related quality of life after veino-arterial ECMO
Time frame: The quality of life will be evaluated from 1 to 12 years after the ECMO
EQ 5D 5L ( description of mobility, personal autonomy, routine activities, pain and discomfort, anxiety and depression and an analog visual scale)
3 secondary outcomes
Analysis by subgroup according to the cardiogenic shock etiology
Time frame: The quality of life will be evaluated from 1 to 12 years after the ECMO
Research of risk factors of an altered quality of life
Time frame: The quality of life will be evaluated from 1 to 12 years after the ECMO
Evaluation of the current comorbidities thanks to Groll index
Time frame: The quality of life will be evaluated from 1 to 12 years after the ECMO
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Veno-arterial Extra-Corporeal Membrane Oxygenation
RecruitingObservational study
Incidence and Morbidity of Cardiac Rhythm Disorders in Patients Assisted by ECMO-VA for Refractory Cardiogenic Shock
Cardiac Rhythm Disorder
RecruitingObservational study
Outcomes of Veno Arterial ECMO
Mortality, Extra Corporeal Membrane Oxygenation
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.
Les Hôpitaux Universitaires de Strasbourg
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 Veno-arterial Extra-Corporeal Membrane Oxygenation and Health Related Quality of Life, 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 1 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: status not confirmed, as of the sponsor's last update on 1 Apr 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of health-related quality of life after veino-arterial ECMO (time frame: The quality of life will be evaluated from 1 to 12 years after the ECMO). The study lists 2 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 1 Apr 2021.