Actively Recruiting

Phase 2
Age: 18Years +
All Genders
ID04282629

Efficacy of 10 Days Intravenous Milrinone to Optimize Brain Blood Flow and Prevent Delayed Cerebral Ischemia in Severe Subarachnoid Hemorrhage

Led by University Hospital, Toulouse · Updated on 2024-09-25

234

Participants Needed

5

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research evaluates the effect of intravenous milrinone on brain blood flow and prevention of delayed cerebral ischemia (DCI) in adults with severe subarachnoid hemorrhage caused by ruptured brain aneurysms. The study focuses on patients who are comatose or sedated shortly after the hemorrhage and aims to determine how 10 days of milrinone compared to placebo affects the volume of brain lesions related to DCI. This randomized, double-blind, multi-center trial addresses a major cause of death and disability where current treatments lack strong scientific evidence. Participants receive either standard care plus milrinone infusion or standard care plus a placebo infusion starting from day 4 to day 14 after aneurysm treatment. Milrinone is given intravenously at a dose of 0.75 micrograms per kilogram per minute. Both groups are closely monitored for signs of vasospasm and may receive additional endovascular treatment if needed. Daily clinical exams and collection of biological data occur during this high-risk period. The study observes complications related to intensive care such as neurological, pulmonary, cardiac, and septic events. Throughout the study, brain CT scans are done at 48 hours post-treatment and again at 1 month to measure DCI lesion volumes. Neurological outcomes, quality of life, and mortality are assessed at multiple points up to one year. Safety is monitored continuously, and detailed data on complications and time spent in intensive care are recorded. This comprehensive follow-up helps researchers evaluate the impact of milrinone on brain injury and recovery after severe subarachnoid hemorrhage.

CONDITIONS

Brief Title

Cerebral Hemodynamic Optimization by Milrinone to Prevent Delayed Cerebral Ischemia

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Severe subarachnoid hemorrhage (WFNS IV or V) with coma or sedation on day 3
  • No pre-existing neurological disability (modified Rankin score 0-2)
  • Affiliated with social security or equivalent
  • Not under legal guardianship or judicial protection
  • Signed informed consent obtained from a relative or trusted person after clear information
Not Eligible

You will not qualify if you...

  • Non-severe subarachnoid hemorrhage (WFNS I, II, III)
  • Major complications during aneurysm treatment threatening short-term survival
  • Heart failure needing inotropic drugs at randomization
  • Intracranial hypertension (ICP >25 mmHg for at least 20 minutes) at randomization
  • Severe obstructive heart disease
  • Atrial flutter or atrial fibrillation
  • Hemodynamic instability due to hypotension or severe low blood volume
  • Septic shock
  • Acute or chronic kidney failure (creatinine clearance <50 ml/min)
  • Major electrolyte disturbances (potassium <3 mmol/L)
  • Known allergy to milrinone or its ingredients
  • Early limitation of life-sustaining care
  • Pregnancy or breastfeeding
  • Permanent contraindications to MRI
  • Participation in another interventional clinical trial

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 11 days

Participants receive intravenous milrinone or placebo from Day 4 to Day 14 after aneurysm treatment, along with standard care. Clinical examinations and biological data are collected daily during this period. Occurrence of vasospasm is closely monitored and endovascular treatment may be provided if needed.

Daily visits from Day 4 to Day 14

Follow-up

Duration - 1 year

Participants undergo CT scans and assessments of neurological prognosis, quality of life, and mortality at 1 month, 3 months, 6 months, and 1 year after treatment. Adverse events and complications are monitored throughout this period.

Visits at 1 month, 3 months, 6 months, and 1 year

Trial Site Locations

Total: 5 locations

1

University Hospital Bordeaux

Bordeaux, France

Active, Not Recruiting

2

CHUGA

Grenoble, France

Active, Not Recruiting

3

University Hospital of La Réunion

La Réunion, France

Actively Recruiting

4

HCL

Lyon, France

Actively Recruiting

5

University Hospital of Toulouse

Toulouse, France

Actively Recruiting

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Research Team

T

Thomas Geeraerts, MD PhD

N

Nadera AINAOUI

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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