Status:
RECRUITING
Cerebral Hemodynamic Optimization by Milrinone to Prevent Delayed Cerebral Ischemia
Lead Sponsor:
University Hospital, Toulouse
Conditions:
Aneurysmal Subarachnoid Hemorrhage
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Detailed Description
After SAHa, approximately 28% of patients will present DCI. DCI is a major cause of death and disability and will condition the neurological prognosis. Its treatment is not really codified, because of...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
234 Patients enrolled
Trial Details
Trial ID
NCT04282629
Start Date
July 25 2021
End Date
July 1 2025
Last Update
September 25 2024
Active Locations (5)
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1
University Hospital Bordeaux
Bordeaux, France
2
CHUGA
Grenoble, France
3
University Hospital of La Réunion
La Réunion, France
4
HCL
Lyon, France