NCT04282629 Cerebral Hemodynamic Optimization by Milrinone to Prevent Delayed Cerebral Ischemia
| NCT ID | NCT04282629 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University Hospital, Toulouse |
| Condition | Aneurysmal Subarachnoid Hemorrhage |
| Study Type | INTERVENTIONAL |
| Enrollment | 234 participants |
| Start Date | 2021-07-25 |
| Primary Completion | 2025-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 234 participants in total. It began in 2021-07-25 with a primary completion date of 2025-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Thomas Geeraerts, MD PhD
PRINCIPAL INVESTIGATOR
University Hospital, Toulouse
Frequently Asked Questions
Who can join the NCT04282629 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Aneurysmal Subarachnoid Hemorrhage. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04282629 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04282629 currently recruiting?
Yes, NCT04282629 is actively recruiting participants. Contact the research team at geeraerts.t@chu-toulouse.fr for enrollment information.
Where is the NCT04282629 trial being conducted?
This trial is being conducted at Bordeaux, France, Grenoble, France, La Réunion, France, Lyon, France and 1 additional location.
Who is sponsoring the NCT04282629 clinical trial?
NCT04282629 is sponsored by University Hospital, Toulouse. The principal investigator is Thomas Geeraerts, MD PhD at University Hospital, Toulouse. The trial plans to enroll 234 participants.