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New treatment option for Brain-dead Organ Donors
Official title Anesthesia sTrategy foR Organ Procurement In braiN dEath
ClinicalTrials.gov ID: NCT07166991
What this study is testing
What is Volatile anesthetic?
Volatile anesthetic is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for brain-dead organ donors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The optimal anesthetic strategy during organ procurement in brain-dead donors remains unknown. The administration of anesthetic drugs in this setting aims to preserve hemodynamic stability in the face of reflex responses mediated by preserved spinal activity.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Eligible adult brain-dead donor hospitalized in intensive care unit in one of the participating center:
- Confirmed diagnosis of brain death according to French public health code.
- Ongoing organ donation procedure managed by the local organ procurement coordination team with confirmation of the potential procurement of at least...
- Transfer to the operating room for the organ procurement procedure scheduled for the next 6 hours and anesthesia team alerted.
- Information of the patient's next of kin by the investigator and absence of opposition to research confirmed by the testimony of the next of kin...
You likely can't join if
- Age \< 18 years.
- DCD (donation after circulatory death) donors.
- Ongoing extracorporeal circulation at the time of death.
- Hemodynamic instability at the screening visit defined by a noradrenalin dose \> 1 µg/kg/min.
- Contraindication to the implementation of the anesthetic interventions evaluated in the trial:
- Prior history of opioid or volatil anesthetic agents allergy.
See the full eligibility criteria
- Eligible adult brain-dead donor hospitalized in intensive care unit in one of the participating center:
- Confirmed diagnosis of brain death according to French public health code.
- Ongoing organ donation procedure managed by the local organ procurement coordination team with confirmation of the potential procurement of at least one intra-abdominal or intra-thoracic organ.
- Transfer to the operating room for the organ procurement procedure scheduled for the next 6 hours and anesthesia team alerted.
- Information of the patient's next of kin by the investigator and absence of opposition to research confirmed by the testimony of the next of kin according to French public health code.
- Age \< 18 years.
- DCD (donation after circulatory death) donors.
- Ongoing extracorporeal circulation at the time of death.
- Hemodynamic instability at the screening visit defined by a noradrenalin dose \> 1 µg/kg/min.
- Contraindication to the implementation of the anesthetic interventions evaluated in the trial:
- Prior history of opioid or volatil anesthetic agents allergy.
- Prior personal or family history of malignant hyperthermia or history of myopathy at risk of malignant hyperthermia.
- Opposition to the research expressed by the patient during his or her lifetime and documented by the next of kin.
The study team makes the final eligibility decision.
Where it's taking place
- Grenoble, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Grenoble, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.