BridgeMD
New treatment option for Subarachnoid Hemorrhage, Aneurysmal
Official title The Anaesthetic Ketamine as Treatment for Patients With Severe Acute Brain Injury
ClinicalTrials.gov ID: NCT05095857
What this study is testing
What is S-ketamine?
S-ketamine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for subarachnoid hemorrhage, aneurysmal.
Also referred to as Esketamine.
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
- Cortical spreading depolarisations are pathological depolarisation waves that occur frequently after severe acute brain injury and has been associated with poor outcome. S-ketamine has been shown to inhibit cortical spreading depolarisations.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
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
- Age ≥ 18 years.
- Admitted to the NICU with a diagnosis of traumatic brain injury (TBI), aneurysmal subarachnoid haemorrhage (aSAH) or spontaneous intracerebral...
- Planned for surgery with a supratentorial craniotomy or craniectomy.
- Expected to continue sedation and mechanical ventilation after surgery.
You likely can't join if
- Neither patient or next of kin understand Danish or English.
- Known allergy to S-ketamine (the active pharmaceutical ingredient or the excipients).
- Wake-up call to occur immediately after surgery.
- Pregnancy (all female participants aged ≤ 50 years will have a urine or blood hCG taken to control for pregnancy).
- Active anti-psychotic treatment before admission.
- Current abuse of ketamine.
See the full eligibility criteria
- Age ≥ 18 years.
- Admitted to the NICU with a diagnosis of traumatic brain injury (TBI), aneurysmal subarachnoid haemorrhage (aSAH) or spontaneous intracerebral haemorrhage (ICH).
- Planned for surgery with a supratentorial craniotomy or craniectomy.
- Expected to continue sedation and mechanical ventilation after surgery.
- Neither patient or next of kin understand Danish or English.
- Known allergy to S-ketamine (the active pharmaceutical ingredient or the excipients).
- Wake-up call to occur immediately after surgery.
- Pregnancy (all female participants aged ≤ 50 years will have a urine or blood hCG taken to control for pregnancy).
- Active anti-psychotic treatment before admission.
- Current abuse of ketamine.
- Decision to withdraw active treatment.
- ICH secondary to a known brain tumour at the time of inclusion. Since this is an emergency trial informed consent will be obtained from a trial guardian before inclusion of the participant, and informed consent will be...
The study team makes the final eligibility decision.
Where it's taking place
- Copenhagen, Denmark
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 Copenhagen, Denmark. 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.