Using Milrinone to Improve Blood Flow and Prevent Brain Damage After Aneurysm Bleeding
Efficacy of 10 Days Intravenous Milrinone Treatment to Optimize Cerebral Hemodynamic and Prevent Delayed Cerebral Ischemia (DCI) in Patients with Severe Subarachnoid Hemorrhage Due to Intracranial Aneurysm Rupture
This study is testing if the drug milrinone can help improve blood flow and prevent brain damage in patients who have had a severe brain bleed from an aneurysm.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 234 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Toulouse Academic / other |
| Locations | 5 sites (Bordeaux and 4 other locations) |
| Trial ID | NCT04282629 on ClinicalTrials.gov |
What this trial studies
This study is a randomized, multi-center, double-blind trial that investigates the effectiveness of intravenous milrinone in optimizing cerebral blood flow and preventing delayed cerebral ischemia (DCI) in patients who have suffered a severe subarachnoid hemorrhage due to an aneurysm rupture. The trial will compare the effects of milrinone against a placebo over a period of 10 days, focusing on patients who are comatose or sedated. The primary outcome will be assessed through CT imaging to measure the volume of DCI lesions one month after treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with severe subarachnoid hemorrhage (WFNS IV-V) who are comatose or require sedation.
Not a fit: Patients with non-severe subarachnoid hemorrhage or those with significant pre-existing neurological disabilities will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the incidence of delayed cerebral ischemia and improve neurological outcomes for patients after a severe aneurysmal subarachnoid hemorrhage.
How similar studies have performed: While there is limited strong evidence for the efficacy of milrinone in preventing DCI, this approach is novel and has not been extensively tested in this specific context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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. Exclusion Criteria: * 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 interventional study
Where this trial is running
Bordeaux and 4 other locations
- University Hospital Bordeaux — Bordeaux, France (Active_not_recruiting)
- Chuga — Grenoble, France (Active_not_recruiting)
- University Hospital of La Réunion — La Réunion, France (Recruiting)
- Hcl — Lyon, France (Recruiting)
- University Hospital of Toulouse — Toulouse, France (Recruiting)
Study contacts
- Principal investigator: Thomas Geeraerts, MD PhD — University Hospital, Toulouse
- Study coordinator: Thomas Geeraerts, MD PhD
- Email: geeraerts.t@chu-toulouse.fr
- Phone: 056-177-2100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.