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Cerebral Hemodynamic Optimization by Milrinone to Prevent Delayed Cerebral Ischemia

NCT04282629 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 234

Last updated 2024-09-25

No results posted yet for this study

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.

Conditions

  • Aneurysmal Subarachnoid Hemorrhage

Interventions

DRUG

Milrinone Injection

administration of milrinone (0.75 μg / kg / min, intravenous) from Day 4 to Day 14

OTHER

Placebo

administration of placebo (intravenous glucose 5%) from Day 4 to Day 14

Sponsors & Collaborators

  • University Hospital, Toulouse

    lead OTHER

Principal Investigators

  • Thomas Geeraerts, MD PhD · University Hospital, Toulouse

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-25
Primary Completion
2025-07-31
Completion
2025-07-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04282629 on ClinicalTrials.gov