Milrinone Infusion for VAsospam Treatment in Subarachnoid hemoRrhage

Launched by UNIVERSITY HOSPITAL, ANGERS · Apr 22, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called Milrinone to treat vasospasm, a serious complication that can occur after a type of bleeding in the brain called subarachnoid hemorrhage (SAH). Vasospasm happens when blood vessels in the brain narrow, which can lead to reduced blood flow and can worsen a patient’s condition. The researchers hope that giving Milrinone through an IV will help improve recovery in patients who experience this complication within a few hours of diagnosis.

Eligible participants for this trial include adults who are hospitalized for their first episode of vasospasm due to aneurysmal SAH. To qualify, patients must have their vasospasm diagnosed with a CT scan and be included in the study within 6 hours of that diagnosis. Throughout the trial, participants will be randomly assigned to receive either Milrinone or a placebo (a substance with no active medication) and will be monitored for three months to see how well they recover. This study is important because it could lead to better treatment options for patients suffering from this serious condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adult patients hospitalized for aneurysmal SAH
• • First episode of vasospasm, with a diagnosis confirmed on cerebral arterial CT-scanner
• • Delay between diagnosis of vasospasm (done by CT-scanner) and inclusion ≤6 hours
• • Informed consent from a legal representative, or emergency procedure
• Exclusion Criteria:
• • Initial Glasgow score at 3 with a bilateral mydriasis
• • Moribund patient
• • Contraindication to Milrinone (notably obstructive cardiomyopathy...)
• • Cerebral infarction in the vasospasm area already present on the CT-scanner at the time of diagnosis (lack of expected benefit of treatment in this case according to medical judgement)
• • Cardiac failure requiring inotrope administration at the time of randomisation
• • Uncontrolled elevated intra-cranial pressure (i.e. ICP\>25 mmHg for more than 20 minutes)
• • Patient with flutter or cardiac arrhythmia (atrial fibrillation) poorly tolerated
• • Major metabolic disturbance (uncorrected hypokalaemia \<3 mmol/L)
• • Non-affiliation to French health care coverage,
• • Pregnant, breastfeeding or parturient woman
• • Adult deprived of their liberty by judicial or administrative decision
• • Adult under compulsory psychiatric care
• • Adult patient protected under the law (guardianship or trusteeship)
• • Inclusion in an interventional study using Milrinone, or evaluating a treatment of cerebral vasospasm or with the same primary endpoint (mRS at 3 months).