Efficacy of 10 Days Intravenous Milrinone Treatment to Optimize Cerebral Hemodynamic and Prevent Delayed Cerebral Ischemia (DCI) in Patients with Severe Subarachnoid Hemorrhage Due to Intracranial Aneurysm Rupture

Who is this study for? Patients with Aneurysmal Subarachnoid Hemorrhage
What treatments are being studied? Milrinone Injection
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
University Hospital Bordeaux
ACTIVE_NOT_RECRUITING
Bordeaux
CHUGA
ACTIVE_NOT_RECRUITING
Grenoble
University Hospital of La Réunion
RECRUITING
La Réunion
HCL
RECRUITING
Lyon
University Hospital of Toulouse
RECRUITING
Toulouse
Contact Information
Primary
Thomas Geeraerts, MD PhD
geeraerts.t@chu-toulouse.fr
056-177-2100
Backup
Nadera AINAOUI
nadera.ainaoui@inserm.fr
056-177-2498
Time Frame
Start Date: 2021-07-25
Estimated Completion Date: 2025-07
Participants
Target number of participants: 234
Treatments
Experimental: Milrinone
milrinone group benefiting from an identical treatment to the standard care group and in addition, administration of milrinone (0.75 μg / kg / min, intravenous) from Day 4 to Day 14. In case of suspicion of vasospasm and after ineffective effect of medical measures (euvolemia and increase in mean arterial pressure), an endovascular treatment will be possible. The occurrence of vasospasm will be monitored closely with clinical examination and cerebral tissue oxygen pressure (PtiO2). From D4 to D14, general and biological data, clinical examination will be collected daily. Intensive care unit complications (neurologic, pulmonary, cardiac and septic complications) will be collected. At 1 month, the volume of DCI lesions will be measured on CT scan. Neurologic prognosis, quality of life and mortality will be studied at 1 month, 3 month, 6 month and 1 year. Adverse events will be monitored closely.
Placebo_comparator: Standard Care
The standard care group will follow the recommended management of SAHa and will receive a placebo (intravenous glucose 5%) from Day 4 to Day 14. In case of suspicion of vasospasm and after ineffective effect of medical measures (euvolemia and increase in mean arterial pressure), an endovascular treatment will be possible. The occurrence of vasospasm will be monitored closely with clinical examination and cerebral tissue oxygen pressure (PtiO2). From D4 to D14, general and biological data, clinical examination will be collected daily. Intensive care unit complications (neurologic, pulmonary, cardiac and septic complications) will be collected. At 1 month, the volume of DCI lesions will be measured on CT scan. Neurologic prognosis, quality of life and mortality will be studied at 1 month, 3 month, 6 month and 1 year. Adverse events will be monitored closely.
Authors
Ségolène Mrozeck, Thomas GEERAERTS
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Toulouse

This content was sourced from clinicaltrials.gov