Cerebral Hemodynamic Optimization by Milrinone to Prevent Delayed Cerebral Ischemia

Launched by UNIVERSITY HOSPITAL, TOULOUSE · Feb 20, 2020

Keywords

ClinConnect Summary

This clinical trial is investigating whether a medication called milrinone can help improve blood flow in the brain and prevent delayed cerebral ischemia (DCI) in patients who have had a severe subarachnoid hemorrhage (a type of bleeding in the brain caused by a ruptured aneurysm). The trial will involve patients who are in a coma or heavily sedated and will compare the effects of milrinone to a placebo (a substance with no active medication) over a period of ten days. Researchers are particularly interested in how this treatment impacts brain scans taken one month later to see if fewer brain injuries occur due to DCI.

To participate in this study, patients must be at least 18 years old and have severe subarachnoid hemorrhage that makes it difficult to assess their neurological status. They should not have any pre-existing severe neurological conditions and must have someone who can provide informed consent on their behalf. Participants can expect to receive either milrinone or a placebo along with standard care, and the study aims to gather important information that may help improve treatment outcomes for similar patients in the future. If you or a loved one are interested in this trial, it would be a good idea to discuss it further with a healthcare provider to understand all the options and implications.

Gender

ALL

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