Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Extracorporeal Membrane Oxygenation Evaluated by Transcranial Doppler. (ECMO-DTC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03457090
Recruitment Status : Unknown
Verified April 2018 by University Hospital, Toulouse.
Recruitment status was:  Recruiting
First Posted : March 7, 2018
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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 withdrawal of ECMO.

Condition or disease Intervention/treatment Phase
Extracorporeal Membrane Oxygenation Complication Other: Examination : a TCD and Trans-Thoracic Echocardiography Not Applicable

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Prevention
Official Title: Extracorporeal Membrane Oxygenation and Cerebral Blood Flow Velocity Evaluated by Transcranial Doppler
Actual Study Start Date : April 5, 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Patient treated with ECMO
Patient treated with ECMO will have Examination : a TCD and Trans-Thoracic Echocardiography (TTE)
 Other: Examination : a TCD and Trans-Thoracic Echocardiography

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.
Other Name: Examination that involves a TCD and an TTE


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Cerebral blood flow velocities evolution [ Time Frame: 24 hours ]
    Cerebral blood flow velocities evolution over the time

  2. 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.


Secondary Outcome Measures :
  1. Relation between acute neurologic injury and variation of CBFV [ Time Frame: 24 hours ]
    Relation between acute neurologic injury and variation of CBFV detected by TCD.

  2. Modification of the CBFV detected by TCD after the withdrawal of the ECMO. [ Time Frame: 24 hours ]
    Modification of the cerebral blood flow velocity (CBFV) detected by TCD after the withdrawal of the ECMO.

  3. Relation between the CBFV, the NIRS, the cardiac flow and the ECMO flow. [ Time Frame: 24 hours ]
    Relation between the CBFV (cerebral blood flow velocity), the Near Infrared Spectroscopy (NIRS), the cardiac flow and the ECMO flow.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patient who receiving ECMO therapy

Exclusion Criteria:

  • cervico-encephalic vasculopathy
  • lacked an acoustic window allowing for adequate TCD examination
  • stroke in medical past.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03457090


Contacts
Layout table for location contacts
Contact: Fanny BOUNES, MD 5 61 32 23 11 ext 33 bounes.f@chu-toulouse.fr
Contact: Isabelle OLIVIER, PhD 5 61 77 70 51 ext 33 olivier.i@chu-toulouse.fr

Locations
Layout table for location information
France
University Hospital Toulouse Recruiting
Toulouse, France, 31059
Contact: Fanny BOUNES, MD    5 61 32 23 11 ext 33    bounes.f@chu-toulouse.fr   
Contact: Isabelle Olivier, PhD    5 61 77 70 51 ext 33    olivier.i@chu-toulouse.fr   
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Layout table for investigator information
Principal Investigator: Fanny BOUNES, MD University Hospital, Toulouse
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT03457090    
Other Study ID Numbers: RC31/18/0042
2018-A00320-55 ( Other Identifier: ID-RCB )
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Toulouse:
neurologic complication, transcranial Doppler ultrasound