Aneurysmal Subarachnoid HemorrhagePhase 2OPTIMILNCT04282629
Cerebral Hemodynamic Optimization by Milrinone to Prevent Delayed Cerebral Ischemia
A Phase 2 study testing Milrinone Injection in people with Aneurysmal Subarachnoid Hemorrhage, run by University Hospital, Toulouse at 5 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aneurysmal Subarachnoid Hemorrhage
- What is being tested?
- Milrinone Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 234 participants
- Where
- 5 sitesFrance
- Study dates
- 25 Jul 2021to Jul 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites, 3 recruiting
- Active, not recruiting
University Hospital Bordeaux
Bordeaux
- Active, not recruiting
CHUGA
Grenoble
- Recruiting
University Hospital of La Réunion
La Réunion
Romain ASMOLOV, MD
- Recruiting
HCL
Lyon
Baptiste BALANCA, MD
Baptiste BALANCA
- Recruiting
University Hospital of Toulouse
Toulouse
GEERAERTS Thomas, MD
Thomas GEERAERTS, MD
About this study
Official title: 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
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.
Read the detailed description
After SAHa, approximately 28% of patients will present DCI. DCI is a major cause of death and disability and will condition the neurological prognosis. Its treatment is not really codified, because of the absence of scientific proof of good level. Milrinone, an inhibitor of type III phosphodiesterase, seems particularly interesting in the management of DCI. This molecule has indeed a powerful vasodilator action. In addition, its anti-inflammatory effects could inhibit the abnormal proliferation of vascular smooth muscle cells and the remodelling observed in patients with DCI via an action on interleukin-6. Finally, because of its positive inotropic effect, it is an interesting choice in these patients with neurogenic cardiomyopathy where the administration of catecholamines is to be avoided. Strong evidence for efficacy of milrinone in the treatment and / or prevention of DCI is still lacking. All patients will benefit from a computed tomography (CT) brain imaging at 48 hrs following aneurysm treatment to define baseline imaging. The standard care (SC) group will follow the recommended management of SAHa and will receive a placebo (intravenous glucose 5%) from day 4 to day 14. The milrinone (M) group will receive, in addition to standard care, 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 day 4 to day 14, 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.
- Conditions
- Aneurysmal Subarachnoid Hemorrhage
- Being tested
- Milrinone Injection, Placebo
- Keywords
- Milrinone, Vasospasm, Delayed Cerebral Ischemia
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Milrinone InjectionDrug
administration of milrinone (0.75 μg / kg / min, intravenous) from Day 4 to Day 14
PlaceboOther
administration of placebo (intravenous glucose 5%) from Day 4 to Day 14
| Study group | Role | What they receive |
|---|---|---|
| Milrinone | Experimental | "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. Receives: Drug: Milrinone Injection |
| Standard Care | Placebo comparator | 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
volume of delayed cerebral ischemia lesions
volume of DCI lesions measured on CT scan and validated by Magnetic Resonance Imaging (MRI) imaging at 1 month
Measured: 1 month
Secondary outcomes (21)
Radiological parameters on CT at 1 month
percentage of patients with DCI lesions
Measured: 1 month
Evolution in intensive care: Neurological complications 1
number of episodes of PtiO2 below the ischemic threshold in intensive care: PtiO2 <20 mmHg (moderate hypoxia) and <15 mm Hg (severe hypoxia) for at least 15 minutes
Measured: 1 month
Evolution in intensive care: Neurological complications 2
total duration of episodes of PtiO2 <20 mm Hg (moderate hypoxia) and <15 mm Hg (severe hypoxia)
Measured: 1 month
Evolution in intensive care: Neurological complications 3
number of recourse to an endovascular treatment
Measured: 1 month
Evolution in intensive care: Neurological complications 4
intracranial hypertension in intensive care: ICP> 20 mmHg for at least 15 minutes.
Measured: 1 month
Number and type of non-neurological complications
non-neurological complications
Measured: 1 month
Number of days in intensive care
Number of days in intensive care
Measured: 1 month
Number of days with mechanical ventilation
Number of days with mechanical ventilation
Measured: 1 month
neurological prognosis at 1 month: Rankin score
evaluated by the modified Rankin score (good prognosis: mRS 0, 1 and 2 / poor prognosis: mRS 3, 4 and 5)
Measured: 1 month
neurological prognosis at 1 month: Glasgow Outcome scale
evaluated by the Glasgow Outcome Scale (GOS) (good prognosis: GOS 4 and 5 / poor prognosis: GOS 1, 2 and 3).
Measured: 1 month
neurological prognosis at 3 month: Rankin score
evaluated by the modified Rankin score (good prognosis: mRS 0, 1 and 2 / poor prognosis: mRS 3, 4 and 5)
Measured: 3 month
neurological prognosis at 3 month: Glasgow Outcome scale
evaluated by the the Glasgow Outcome Scale (good prognosis: GOS 4 and 5 / poor prognosis: GOS 1, 2 and 3)
Measured: 3 month
neurological prognosis at 6 month: Rankin score
evaluated by the modified Rankin score (good prognosis: mRS 0, 1 and 2 / poor prognosis: mRS 3, 4 and 5)
Measured: 6 month
neurological prognosis at 6 month: Glasgow Outcome scale
evaluated by the the Glasgow Outcome Scale (good prognosis: GOS 4 and 5 / poor prognosis: GOS 1, 2 and 3)
Measured: 6 month
neurological prognosis at 1 year: Rankin score
evaluated by the modified Rankin score (good prognosis: mRS 0, 1 and 2 / poor prognosis: mRS 3, 4 and 5)
Measured: 1 year
neurological prognosis at 1 year: Glasgow Outcome scale
evaluated by the Glasgow Outcome Scale (good prognosis: GOS 4 and 5 / poor prognosis: GOS 1, 2 and 3)
Measured: 1 year
Mortality at 1 month
Mortality at 1 month
Measured: 1 month
Mortality at 3 month
Mortality at 3 month
Measured: 3 month
Mortality at 6 month
Mortality at 6 month
Measured: 6 month
Mortality at 1 year
Mortality at 1 year
Measured: 1 year
number of days of hospitalization
number of days of hospitalization
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start25 Jul 2021
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aneurysmal Subarachnoid HemorrhageStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group milrinone versus group placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 234 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Geeraerts, MD PhD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04282629
- Sponsor's protocol ID
- RC31/18/0472
- Acronym
- OPTIMIL
- Status last verified
- Sep 2024
- First submitted
- 17 Feb 2020
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04282629
- Acronym / sponsor ID
- OPTIMIL / RC31/18/0472
- Conditions
- Aneurysmal Subarachnoid Hemorrhage
- Keywords
- Milrinone, Vasospasm, Delayed Cerebral Ischemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 234 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 25 Jul 2021 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 25 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
After SAHa, approximately 28% of patients will present DCI. DCI is a major cause of death and disability and will condition the neurological prognosis. Its treatment is not really codified, because of the absence of scientific proof of good level. Milrinone, an inhibitor of type III phosphodiesterase, seems particularly interesting in the management of DCI. This molecule has indeed a powerful vasodilator action. In addition, its anti-inflammatory effects could inhibit the abnormal proliferation of vascular smooth muscle cells and the remodelling observed in patients with DCI via an action on interleukin-6. Finally, because of its positive inotropic effect, it is an interesting choice in these patients with neurogenic cardiomyopathy where the administration of catecholamines is to be avoided. Strong evidence for efficacy of milrinone in the treatment and / or prevention of DCI is still lacking. All patients will benefit from a computed tomography (CT) brain imaging at 48 hrs following aneurysm treatment to define baseline imaging. The standard care (SC) group will follow the recommended management of SAHa and will receive a placebo (intravenous glucose 5%) from day 4 to day 14. The milrinone (M) group will receive, in addition to standard care, 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 day 4 to day 14, 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Group milrinone versus group placebo
| Arm | Type | Receives |
|---|---|---|
| Milrinone | Experimental | Drug: Milrinone Injection"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. |
| Standard Care | Placebo comparator | Other: PlaceboThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Milrinone Injectionadministration of milrinone (0.75 μg / kg / min, intravenous) from Day 4 to Day 14 | Drug | Milrinone |
| Placeboadministration of placebo (intravenous glucose 5%) from Day 4 to Day 14 | Other | Standard Care |
Primary outcome
volume of delayed cerebral ischemia lesions
Time frame: 1 month
volume of DCI lesions measured on CT scan and validated by Magnetic Resonance Imaging (MRI) imaging at 1 month
21 secondary outcomes
Radiological parameters on CT at 1 month
Time frame: 1 month
Evolution in intensive care: Neurological complications 1
Time frame: 1 month
Evolution in intensive care: Neurological complications 2
Time frame: 1 month
Evolution in intensive care: Neurological complications 3
Time frame: 1 month
Evolution in intensive care: Neurological complications 4
Time frame: 1 month
Number and type of non-neurological complications
Time frame: 1 month
Number of days in intensive care
Time frame: 1 month
Number of days with mechanical ventilation
Time frame: 1 month
neurological prognosis at 1 month: Rankin score
Time frame: 1 month
neurological prognosis at 1 month: Glasgow Outcome scale
Time frame: 1 month
neurological prognosis at 3 month: Rankin score
Time frame: 3 month
neurological prognosis at 3 month: Glasgow Outcome scale
Time frame: 3 month
neurological prognosis at 6 month: Rankin score
Time frame: 6 month
neurological prognosis at 6 month: Glasgow Outcome scale
Time frame: 6 month
neurological prognosis at 1 year: Rankin score
Time frame: 1 year
neurological prognosis at 1 year: Glasgow Outcome scale
Time frame: 1 year
Mortality at 1 month
Time frame: 1 month
Mortality at 3 month
Time frame: 3 month
Mortality at 6 month
Time frame: 6 month
Mortality at 1 year
Time frame: 1 year
number of days of hospitalization
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Geeraerts, MD PhD principal investigator
University Hospital, Toulouse
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Milrinone Injection in people with Aneurysmal Subarachnoid Hemorrhage, run by University Hospital, Toulouse at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas Geeraerts, MD PhD (056-177-2100 ext. 33, geeraerts.t@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
volume of delayed cerebral ischemia lesions (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.