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New treatment option for Aneurysmal Subarachnoid Hemorrhage
Official title Cerebral Hemodynamic Optimization by Milrinone to Prevent Delayed Cerebral Ischemia
ClinicalTrials.gov ID: NCT04282629
What this study is testing
What is Milrinone Injection?
Milrinone Injection is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for aneurysmal subarachnoid hemorrhage.
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 present study is a randomized, multi-center, double-blind, prospective study that tests the efficacy of intravenous milrinone to optimize cerebral hemodynamic and prevent delayed cerebral ischemia (DCI) during the high-risk period (day 4- day 14) in patients with severe subarachnoid hemorrhage due to intracranial aneurysm rupture (SAHa) (WFNS IV-V). The main objective is to evaluate, in comatose patients and / or sedated on D3 following a severe SAHa (WFNS IV -V), the effect of 10 days of milrinone versus placebo, in addition to the usual management, on the volume of DCI lesions measured on CT scan at 1 month.
- Phase 2: a mid-size study of how well it works
- 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
- patients with severe SAHa (WFNS IV and V,) whose neurological examination is impossible because of coma (Glasgow coma score of 8 or less) or need for...
- absence of pre-existing neurological handicap (mRS 0-2)
- major patient (≥ 18 years)
- affiliation to social security or benefiting through a third person
- free patient, without tutorship or curatorship or under judicial protection
You likely can't join if
- patients with non-severe SAHa (WFNS I, II and III)
- Occurrence of a major complication (haemorrhagic or ischaemic) documented during the procedure of securing the aneurysm and endangering the...
- heart failure requiring inotropic administration at the time of randomization
- ICHT at the time of randomisation (ICP\> 25 mmHg for at least 20 min)
- known severe obstructive heart diseases
- flutter patient or atrial fibrillation
See the full eligibility criteria
- patients with severe SAHa (WFNS IV and V,) whose neurological examination is impossible because of coma (Glasgow coma score of 8 or less) or need for sedation at D3
- absence of pre-existing neurological handicap (mRS 0-2)
- major patient (≥ 18 years)
- affiliation to social security or benefiting through a third person
- free patient, without tutorship or curatorship or under judicial protection
- obtaining a signed informed consent by a relative (or the person of trust) after clear and fair information about the study.
- patients with non-severe SAHa (WFNS I, II and III)
- Occurrence of a major complication (haemorrhagic or ischaemic) documented during the procedure of securing the aneurysm and endangering the short-term vital prognosis
- heart failure requiring inotropic administration at the time of randomization
- ICHT at the time of randomisation (ICP\> 25 mmHg for at least 20 min)
- known severe obstructive heart diseases
- flutter patient or atrial fibrillation
- hypotension and / or severe hypovolemia with hemodynamic instability
- septic shock
- acute / chronic renal insufficiency (Cl \<50ml / min)
- major hydroelectrolytic disorders (hypokalemia \<3 mmol / L)
- known hypersensitivity to milrinone or any of the excipients
- early limitation of life-sustaining care
- pregnancy, breastfeeding
- permanent contraindications to MRI
- participation in another clinical treatment study
The study team makes the final eligibility decision.
Where it's taking place
- Bordeaux, France
- Grenoble, France
- La Réunion, France
- Lyon, France
- Toulouse, 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 Bordeaux, France; Grenoble, France; La Réunion, France; Lyon, France; Toulouse, 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.