Extracorporeal Membrane Oxygenation Evaluated by Transcranial Doppler. (ECMO-DTC)
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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
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Condition or disease | Intervention/treatment | Phase |
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Extracorporeal Membrane Oxygenation Complication | Other: Examination : a TCD and Trans-Thoracic Echocardiography | Not Applicable |
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 |

Arm | Intervention/treatment |
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Experimental: Patient treated with ECMO
Patient treated with ECMO will have Examination : a TCD and Trans-Thoracic Echocardiography (TTE)
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Other: Examination : a TCD and Trans-Thoracic Echocardiography
Examination that involves the completion of a TCD and an TTE (Trans-Thoracic Echocardiography) :
Other Name: Examination that involves a TCD and an TTE |
- 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.
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
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 |
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 |
Principal Investigator: | Fanny BOUNES, MD | University Hospital, Toulouse |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
neurologic complication, transcranial Doppler ultrasound |