Ongoing Clinical Trials for Subarachnoid Haemorrhage
There are currently 14 clinical trials investigating new treatments for subarachnoid haemorrhage across several European countries. These studies are testing various medications and approaches to improve outcomes for patients who have experienced bleeding in the space around the brain, often caused by a ruptured aneurysm. The trials focus on preventing complications such as vasospasm and delayed brain injury, as well as managing associated conditions like low sodium levels and inflammation.
Clinical trial locations
- Czechia
- Denmark
- France
- Study of cilostazol and nimodipine combination to improve outcomes in patients with aneurysmal subarachnoid hemorrhage
- Study on Levosimendan for Treating Aneurysmal Subarachnoid Hemorrhage in Intensive Care Patients
- Study on Milrinone for Preventing Delayed Brain Ischemia in Patients with Severe Subarachnoid Hemorrhage
- Study on Milrinone Infusion for Treating Vasospasm in Patients with Aneurysmal Subarachnoid Hemorrhage
- Study on the Effectiveness of Sphenopalatine Block for Headache Relief in Patients with Subarachnoid Hemorrhage Using Lidocaine Hydrochloride
- Study on Urea for Treating Low Sodium Levels in Patients with Brain Hemorrhage
- Germany
- Netherlands
- Sweden
Study of Brain Injury and Concussion Symptoms Using Tau Tracer [18F]RO6958948 in Patients with Traumatic Brain Injury and Hemorrhages
This Swedish trial is studying different types of brain injuries, including subarachnoid haemorrhage, using a special imaging technique called positron emission tomography (PET). The study uses a tracer known as [18F]RO6958948 to help identify where tau protein, which is associated with brain injury, accumulates in the brain.
Who can participate: Participants must be between 18 and 60 years old and stable enough to undergo a PET scan. For those with subarachnoid haemorrhage, they must have been treated in an intensive care unit, and their family must have been informed and not objected to participation.
Who cannot participate: People with mild brain injury (cerebral commotio) or those with intracerebral hemorrhage or traumatic brain injury are excluded.
What the study involves: The main focus is to determine whether tau protein levels are increased in patients with brain injuries compared to people without such injuries. Participants will receive an injection of the tracer and then undergo a PET scan to visualize tau protein in the brain.
Study medication: The investigational agent is [18F]RO6958948, a radiopharmaceutical tracer used for diagnostic imaging that binds to tau proteins, making them visible during PET scans.
Study on Stereotactic Cisternal Lavage Therapy for Patients with Aneurysmal Subarachnoid Hemorrhage Using Urokinase, Nimodipine, and a Drug Combination
This German study is testing a treatment called cisternal lavage therapy, which involves washing out the area around the brain after bleeding has occurred. The treatment uses medications including urokinase and nimodipine delivered through a small tube placed in the brain.
Who can participate: Patients aged 18 to 79 years with severe bleeding (Modified Fisher grade 3 or 4 and Hijdra Score of 20 or more) who have had their aneurysm safely treated either with surgery or endovascular technique. They must have an external ventricular drain in place or need one, and the bleeding must have started within the last 96 hours.
What the study involves: The goal is to see if this treatment can improve recovery and safety for patients. The study will monitor neurological recovery at 6 and 12 months, assess quality of life, and watch for any potential complications.
Study medications: Urokinase helps break down blood clots, while nimodipine helps prevent further brain injury by relaxing blood vessels. These are administered directly into the brain area through a catheter.
Study on the Effectiveness of Sphenopalatine Block for Headache Relief in Patients with Subarachnoid Hemorrhage Using Lidocaine Hydrochloride
This French trial is investigating a pain management technique called sphenopalatine block for treating severe headaches in patients with subarachnoid haemorrhage. The study aims to reduce the need for morphine, a strong pain medication.
Who can participate: Adults aged 18 or older with non-traumatic subarachnoid haemorrhage, WFNS scores of 1 or 2, who are awake and not on a breathing machine, and experiencing pain greater than 3 out of 10 despite usual pain medications.
What the study involves: The primary goal is to demonstrate a 50% reduction in morphine use during the first 72 hours after cerebral arteriography (a brain imaging procedure). The study will also monitor complications from the procedure and patient satisfaction with pain management.
Study medications: The sphenopalatine block uses lidocaine hydrochloride to numb specific nerve areas in the face. Other pain medications used in the study include morphine, nefopam, and paracetamol.
Study on the Safety of EDV2209 for Patients with Brain Bleeding (Subarachnoid Hemorrhage)
This Danish study is testing a new medication called EDV2209, which is designed to inhibit certain proteins that may be involved in the body’s response to brain bleeding.
Who can participate: Adults aged 18 to 80 years with moderate or severe subarachnoid haemorrhage confirmed by CT scan, with symptoms that began less than 8 hours ago. The causative aneurysm must be confirmed and access to deliver treatment directly into the brain’s fluid spaces must be obtained within 8 hours of symptom onset.
What the study involves: The study aims to determine the safety and tolerability of EDV2209 when given directly into the brain’s ventricles. Researchers will monitor for side effects, changes in vital signs, and clinical outcomes using various scales to measure recovery.
Study medication: EDV2209 is a MEK1/2 inhibitor, which blocks specific proteins that may contribute to brain injury after bleeding. It is administered through a method that delivers the medication directly into the brain’s fluid-filled spaces.
Study of cilostazol and nimodipine combination to improve outcomes in patients with aneurysmal subarachnoid hemorrhage
This French trial is examining whether adding cilostazol to the standard treatment with nimodipine can lead to better recovery for patients with bleeding caused by a ruptured brain aneurysm.
Who can participate: Adults aged 18 to 64 years admitted to intensive care with bleeding that occurred within the last 4 days. The aneurysm must have been successfully treated through either surgical clipping or endovascular coiling. Participants must be registered in a national healthcare system.
Who cannot participate: People with severe allergic reactions to the study medications, pregnant or breastfeeding women, those with active bleeding disorders, severe heart conditions, severe liver disease or kidney failure, uncontrolled high blood pressure, or history of previous brain aneurysm or severe head trauma.
What the study involves: The study will compare patients receiving cilostazol tablets (100 mg twice daily) plus nimodipine with those receiving placebo plus nimodipine for 14 days. The goal is to determine if adding cilostazol helps improve patients’ ability to perform daily activities and live independently after six months.
Study medications: Cilostazol helps improve blood flow by preventing blood clots and widening blood vessels. Nimodipine relaxes and widens blood vessels in the brain to improve blood flow and prevent complications after brain bleeding.
Study on Deferoxamine for Patients with Aneurysmal Subarachnoid Hemorrhage
This Dutch study is investigating whether deferoxamine, a medication that binds to excess iron in the body, can improve recovery in patients who have experienced bleeding around the brain.
Who can participate: Adults aged 18 to 85 years with subarachnoid haemorrhage diagnosed by CT scan, with no history of trauma causing the bleeding. Participants must have a saccular intracranial aneurysm confirmed by imaging and must have had successful surgical or endovascular treatment to fix the aneurysm. They must be in good clinical condition with WFNS score of 1-3 and GCS score of 13-15.
What the study involves: The study will monitor the presence of new ischemia (areas of reduced blood flow) at two weeks and six months after treatment. Additionally, it will assess neurological and functional health using various scales, serum ferritin levels, and overall quality of life.
Study medication: Deferoxamine mesilate is an iron-chelating agent administered intravenously. By binding to excess iron, it may help prevent oxidative damage to brain tissues following the hemorrhage.
Study on Levosimendan for Treating Aneurysmal Subarachnoid Hemorrhage in Intensive Care Patients
This French trial is testing whether levosimendan, a medication typically used to manage heart failure, can help reduce complications when added to usual care for patients with brain bleeding.
Who can participate: Adults aged 18 to 75 years hospitalized in a surgical intensive care unit for subarachnoid haemorrhage caused by an aneurysm. Participants must have a clinical score of WFNS Grade I to IV and a Fisher score of 3 or 4, which assess the severity of the condition.
What the study involves: The main goal is to see if levosimendan can reduce the risk of cerebral arterial vasospasm, a narrowing of blood vessels in the brain that can occur after bleeding. The study will monitor vasospasm occurrence within 14 days, death rates, impact on heart function, and recovery scores at six months.
Study medication: Levosimendan is a solution for infusion given directly into the bloodstream. It works by increasing the heart’s sensitivity to calcium, thereby improving cardiac contractility and potentially benefiting brain blood flow.
Study on Milrinone for Preventing Delayed Brain Ischemia in Patients with Severe Subarachnoid Hemorrhage
This French study is exploring whether milrinone can help prevent delayed cerebral ischemia, a serious complication where reduced blood flow to the brain occurs after the initial bleeding event.
Who can participate: Patients aged 18 or older with severe aneurysmal subarachnoid haemorrhage who do not have a pre-existing neurological handicap (mRS scores 0-2). A signed informed consent must be obtained from a relative or trusted person.
What the study involves: Participants will receive milrinone through an infusion for 10 days in addition to usual care. The study will assess the impact on the size of brain lesions as seen on CT scan one month after treatment. It will also monitor the number of days in intensive care, neurological outcomes at various time points up to one year, and quality of life.
Study medication: Milrinone is a phosphodiesterase inhibitor that increases cyclic AMP levels in cells, leading to vasodilation (widening of blood vessels) and improved blood flow to the brain.
Study on Milrinone Infusion for Treating Vasospasm in Patients with Aneurysmal Subarachnoid Hemorrhage
This French trial is evaluating whether milrinone given through intravenous infusion can improve neurological outcomes for patients who develop vasospasm after brain bleeding.
Who can participate: Adult patients hospitalized for aneurysmal subarachnoid haemorrhage who have developed vasospasm confirmed by cerebral angiographic CT scan. The time between vasospasm diagnosis and joining the study must be 6 hours or less. Consent must be given by the patient or a relative.
What the study involves: The primary goal is to evaluate the proportion of patients with a good outcome at 3 months, defined by a modified Rankin score of 2 or less. The study will also assess mortality rates, quality of life, length of hospital stay, and the effectiveness of treatment in reducing blood vessel narrowing.
Study medication: Milrinone is administered as an intravenous infusion at a concentration of 1 mg/ml. It works by inhibiting phosphodiesterase 3, which increases cyclic AMP levels, resulting in vasodilation and improved blood flow.
Study on the Effects of Nadroparin Calcium in Patients with Subarachnoid Hemorrhage
This Dutch study is investigating whether patients treated with a therapeutic dose of nadroparin calcium have a lower risk of death within 30 days compared to those receiving a lower, prophylactic dose.
Who can participate: Adults aged 18 or older with subarachnoid haemorrhage confirmed by CT scan or lumbar puncture, with the causative aneurysm confirmed by imaging. The aneurysm must be treated by coiling within 72 hours of the initial bleeding, and informed consent must be provided before the first dose of study medication.
What the study involves: The study will monitor various outcomes including the 30-day death rate, delayed cerebral ischemia, blood clot complications, bleeding complications, hydrocephalus (fluid buildup in the brain), discharge location, quality of life, cognitive functioning, clinical outcomes, and mortality at six months.
Study medication: Nadroparin calcium is a low molecular weight heparin administered as an injection under the skin. It helps prevent blood clots, which can be a complication after brain hemorrhage.
Study on the Safety and Effectiveness of C1 Esterase Inhibitor and Sodium Chloride for Patients with Aneurysmal Subarachnoid Hemorrhage
This Dutch trial is testing Cinryze, which contains C1 esterase inhibitor, to see if it can help reduce inflammation and improve outcomes by temporarily blocking part of the body’s immune system called the complement system.
Who can participate: Adults aged 18 or older with confirmed aneurysmal subarachnoid haemorrhage on CT scan and a WFNS grade between 1 and 5, which assesses the severity of the bleeding.
What the study involves: The study aims to evaluate the safety and effectiveness of Cinryze in managing the acute phase of bleeding. Participants will receive either Cinryze or placebo through an IV infusion. The study will monitor for delayed cerebral ischemia, complications during hospital stay, and assess neurological condition over 14 days. It will also measure complement system activity in blood and spinal fluid.
Study medication: Cinryze (C1 esterase inhibitor) is already approved for other conditions. It works by inhibiting the C1 component of the complement system, which plays a role in the body’s inflammatory response. The hope is that by limiting inflammation, it can reduce the risk of delayed brain injury.
Summary
The 14 ongoing trials for subarachnoid haemorrhage demonstrate significant research activity across Europe, with a particular concentration of studies in France (six trials) and the Netherlands (three trials). France is leading research efforts with multiple trials exploring different treatment approaches.
Several medications are being tested in multiple studies. Milrinone, a medication that helps widen blood vessels, is the subject of two separate French trials examining its ability to prevent or treat vasospasm and delayed brain ischemia. The trials span a diverse range of therapeutic approaches, including medications that reduce inflammation (dexamethasone, parecoxib, C1 esterase inhibitor), prevent blood clots (nadroparin, cilostazol), improve blood flow (milrinone, levosimendan, nimodipine), and address specific complications such as low sodium levels (urea) and severe headaches (sphenopalatine block).
Most trials focus on patients who have had their aneurysm successfully treated and are examining ways to prevent or manage complications that can occur after the initial bleeding event. These complications include vasospasm (narrowing of blood vessels), delayed cerebral ischemia (reduced blood flow to the brain), and inflammation. The studies generally evaluate outcomes at multiple time points, often including assessments at six months or one year to determine long-term recovery and quality of life.
The research reflects a comprehensive approach to improving outcomes for patients with subarachnoid haemorrhage, addressing not only immediate survival but also long-term functional recovery and quality of life. Many trials use standardized scales such as the modified Rankin Scale and Glasgow Outcome Scale to measure neurological recovery and independence in daily activities.
