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

• ClinicalTrials.gov Identifier: NCT03457090
• Recruitment Status: Unknown
• First Posted: March 7, 2018
• Last Update Posted: April 18, 2018
• Sponsor: University Hospital, Toulouse
• Information provided by (Responsible Party): University Hospital, Toulouse

Tracking Information

• First Submitted Date: February 27, 2018
• First Posted Date: March 7, 2018
• Last Update Posted Date: April 18, 2018
• Actual Study Start Date: April 5, 2018
• Estimated Primary Completion Date: September 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 5, 2018)

• 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 5, 2018)

• 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.
• 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.
• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Extracorporeal Membrane Oxygenation Evaluated by Transcranial Doppler.
• Official Title: Extracorporeal Membrane Oxygenation and Cerebral Blood Flow Velocity Evaluated by Transcranial Doppler
• 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.
• 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 Type: Interventional
• Study Phase: Not Applicable

Study Design

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

• Condition: Extracorporeal Membrane Oxygenation Complication

Intervention

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

Study Arms

Experimental: Patient treated with ECMO

Patient treated with ECMO will have Examination : a TCD and Trans-Thoracic Echocardiography (TTE)

Intervention: Other: Examination : a TCD and Trans-Thoracic Echocardiography

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: March 5, 2018): 30
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 2020
• Estimated Primary Completion Date: September 2020 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT03457090
• Other Study ID Numbers: RC31/18/0042; 2018-A00320-55 ( Other Identifier: ID-RCB )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: University Hospital, Toulouse
• Study Sponsor: University Hospital, Toulouse
• Collaborators: Not Provided

Investigators

• Principal Investigator: Fanny BOUNES, MD; University Hospital, Toulouse

• PRS Account: University Hospital, Toulouse
• Verification Date: April 2018