Extracorporeal Membrane Oxygenation ComplicationECMO-DTCNCT03457090
Extracorporeal Membrane Oxygenation Evaluated by Transcranial Doppler.
A study testing Examination : a TCD and Trans-Thoracic Echocardiography in people with Extracorporeal Membrane Oxygenation Complication, run by University Hospital, Toulouse at 1 site in France.
Trial summary
To determine how venoarterial extracorporeal membrane oxygenation (ECMO) affects cerebral blood flow velocity (CBFV) measured by transcranial doppler (TCD), to determine whether specific changes in cerebral blood flow velocity may be associated with neurologic injury and to determine modifications of CBFV after… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extracorporeal Membrane Oxygenation Complication
- What is being tested?
- Examination : a TCD and Trans-Thoracic Echocardiography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 5 Apr 2018to Sep 2020
- Phase
- Interventional
- 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
Who may be able to join
- adult patient who receiving ECMO therapy
Who cannot join
- cervico-encephalic vasculopathy
- lacked an acoustic window allowing for adequate TCD examination
- stroke in medical past.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital Toulouse
Toulouse, 31059
Fanny BOUNES, MD, 5 61 32 23 11 ext. 33, bounes.f@chu-toulouse.fr
Isabelle Olivier, PhD, 5 61 77 70 51 ext. 33, olivier.i@chu-toulouse.fr
About this study
Official title: Extracorporeal Membrane Oxygenation and Cerebral Blood Flow Velocity Evaluated by Transcranial Doppler
To determine how venoarterial extracorporeal membrane oxygenation (ECMO) affects cerebral blood flow velocity (CBFV) measured by transcranial doppler (TCD), to determine whether specific changes in cerebral blood flow velocity may be associated with neurologic injury and to determine modifications of CBFV after withdrawal of ECMO.
Read the detailed description
Venoarterial Extracorporeal membrane oxygenation (ECMO) is used in adult with refractory cardiac failure as a life-saving measure. Adults treated with ECMO survived to hospital discharge in 21,8% to 65,4% of cases. Neurologic complications such as intracranial hemorrhage, anoxia and ischemia are major causes of death and long-term disability in ECMO patients (7% to 14%). Current neurological monitoring techniques are insufficient to predict which critically ill patient receiving ECMO therapy will suffer from neurologic injury. Even after a clinical suspicion of neurologic injury, diagnosis can be difficult. TCD is commonly used to monitor the CBFV of traumatic brain injury. There are no reports that evaluate CBFV of patients requiring ECMO therapy. Patient will have to do both echocardiography and TCD to evaluate cardiac output and CBFV. We will repeat these dopplers every 24 hours until ECMO withdrawal and one day after explantation.
- Being tested
- Examination : a TCD and Trans-Thoracic Echocardiography
- Keywords
- neurologic complication, transcranial Doppler ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Examination : a TCD and Trans-Thoracic EchocardiographyOther
Also called Examination that involves a TCD and an TTE
Examination that involves the completion of a TCD and an TTE (Trans-Thoracic Echocardiography) :
- To reports clinical parameters at the time of the examination : ECG data: sinus rhythm, atrial or ventricular arrhythmia, state of consciousness, heart rate, O2 saturation
- To review of pharmacological parameters at the time of the examination : presence of sedation; presence, type and dose of catecholamines.
- To collect biological data from the day of the examination : Partial Pressure of O2, PaCO2 (partial pressure) and hematocrit
- To collect possible additional examinations : brain scan, EEG. These are non-invasive exams that do not require patient displacement. Only the samples taken by the medical team as part of the treatment will be analyzed.
| Study group | Role | What they receive |
|---|---|---|
| Patient treated with ECMO | Experimental | Patient treated with ECMO will have Examination : a TCD and Trans-Thoracic Echocardiography (TTE) Receives: Other: Examination : a TCD and Trans-Thoracic Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral blood flow velocities evolution
Cerebral blood flow velocities evolution over the time
Measured: 24 hours
The correlation of Cerebral blood flow velocities with the variation of the cardiac output and ECMO flow.
The correlation with the variation of the cardiac output and ECMO flow.
Measured: 24 hours
Secondary outcomes (3)
Relation between acute neurologic injury and variation of CBFV
Relation between acute neurologic injury and variation of CBFV detected by TCD.
Measured: 24 hours
Modification of the CBFV detected by TCD after the withdrawal of the ECMO.
Modification of the cerebral blood flow velocity (CBFV) detected by TCD after the withdrawal of the ECMO.
Measured: 24 hours
Relation between the CBFV, the NIRS, the cardiac flow and the ECMO flow.
Relation between the CBFV (cerebral blood flow velocity), the Near Infrared Spectroscopy (NIRS), the cardiac flow and the ECMO flow.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2018
- Study start5 Apr 2018
- Primary completionSep 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extracorporeal Membrane Oxygenation ComplicationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patient treated with Venoarterial Extracorporeal membrane oxygenation (ECMO) Realization of transcranial doppler (TCD) of the right and left middle cerebral artery in the first 48 hours of the setting up of the ECMO with joint realization of an Trans-thoracic echocardiography (TTE) then every 24 hours until the end of the using of the ECMO and the realization of TCD and TTE during the 24 hours after removal of the ECMO.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fanny BOUNES, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03457090
- Sponsor's protocol ID
- RC31/18/0042
- Other IDs
- 2018-A00320-55
- Acronym
- ECMO-DTC
- Status last verified
- Apr 2018
- First submitted
- 27 Feb 2018
- Last updated
- 18 Apr 2018
- 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 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extracorporeal Membrane Oxygenation and Cerebral Blood Flow Velocity Evaluated by Transcranial Doppler
- ClinicalTrials.gov ID
- NCT03457090
- Acronym / sponsor ID
- ECMO-DTC / RC31/18/0042
- Keywords
- neurologic complication, transcranial Doppler ultrasound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 5 Apr 2018 (actual)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 7 Mar 2018 (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.
To determine how venoarterial extracorporeal membrane oxygenation (ECMO) affects cerebral blood flow velocity (CBFV) measured by transcranial doppler (TCD), to determine whether specific changes in cerebral blood flow velocity may be associated with neurologic injury and to determine modifications of CBFV after withdrawal of ECMO.
Detailed description
Venoarterial Extracorporeal membrane oxygenation (ECMO) is used in adult with refractory cardiac failure as a life-saving measure. Adults treated with ECMO survived to hospital discharge in 21,8% to 65,4% of cases. Neurologic complications such as intracranial hemorrhage, anoxia and ischemia are major causes of death and long-term disability in ECMO patients (7% to 14%). Current neurological monitoring techniques are insufficient to predict which critically ill patient receiving ECMO therapy will suffer from neurologic injury. Even after a clinical suspicion of neurologic injury, diagnosis can be difficult. TCD is commonly used to monitor the CBFV of traumatic brain injury. There are no reports that evaluate CBFV of patients requiring ECMO therapy. Patient will have to do both echocardiography and TCD to evaluate cardiac output and CBFV. We will repeat these dopplers every 24 hours until ECMO withdrawal and one day after explantation.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patient treated with Venoarterial Extracorporeal membrane oxygenation (ECMO) Realization of transcranial doppler (TCD) of the right and left middle cerebral artery in the first 48 hours of the setting up of the ECMO with joint realization of an Trans-thoracic echocardiography (TTE) then every 24 hours until the end of the using of the ECMO and the realization of TCD and TTE during the 24 hours after removal of the ECMO.
| Arm | Type | Receives |
|---|---|---|
| Patient treated with ECMO | Experimental | Other: Examination : a TCD and Trans-Thoracic EchocardiographyPatient treated with ECMO will have Examination : a TCD and Trans-Thoracic Echocardiography (TTE) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patient who receiving ECMO therapy
Key exclusion criteria (3 listed)
- cervico-encephalic vasculopathy
- lacked an acoustic window allowing for adequate TCD examination
- stroke in medical past.
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 |
|---|---|---|
| Examination : a TCD and Trans-Thoracic EchocardiographyAlso: Examination that involves a TCD and an TTEExamination that involves the completion of a TCD and an TTE (Trans-Thoracic Echocardiography) : * To reports clinical parameters at the time of the examination : ECG data: sinus rhythm, atrial or ventricular arrhythmia, state of consciousness, heart rate, O2 saturation * To review of pharmacological parameters at the time of the examination : presence of sedation; presence, type and dose of catecholamines. * To collect biological data from the day of the examination : Partial Pressure of O2, PaCO2 (partial pressure) and hematocrit * To collect possible additional examinations : brain scan, EEG. These are non-invasive exams that do not require patient displacement. Only the samples taken by the medical team as part of the treatment will be analyzed. | Other | Patient treated with ECMO |
Primary outcome
Cerebral blood flow velocities evolution
Time frame: 24 hours
Cerebral blood flow velocities evolution over the time
The correlation of Cerebral blood flow velocities with the variation of the cardiac output and ECMO flow.
Time frame: 24 hours
The correlation with the variation of the cardiac output and ECMO flow.
3 secondary outcomes
Relation between acute neurologic injury and variation of CBFV
Time frame: 24 hours
Modification of the CBFV detected by TCD after the withdrawal of the ECMO.
Time frame: 24 hours
Relation between the CBFV, the NIRS, the cardiac flow and the ECMO flow.
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
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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.
Fanny BOUNES, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Examination : a TCD and Trans-Thoracic Echocardiography in people with Extracorporeal Membrane Oxygenation Complication, run by University Hospital, Toulouse 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 1 inclusion and 3 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 18 Apr 2018. 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?
Contact Fanny BOUNES, MD (5 61 32 23 11 ext. 33, bounes.f@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral blood flow velocities evolution (time frame: 24 hours). 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 18 Apr 2018.