Ongoing Clinical Trials for Cerebral Haemorrhage
Seven clinical trials are currently investigating new treatments and care strategies for patients with cerebral haemorrhage, including spontaneous brain bleeding, traumatic brain injury, and subarachnoid haemorrhage. Studies are taking place across Europe in Belgium, Denmark, France, Netherlands, Spain, and Sweden, testing treatments ranging from imaging tracers and anti-clotting medications to anti-inflammatory drugs and new safety assessments. (Also known as: Intracerebral hemorrhage, Brain bleeding, Spontaneous intracerebral hemorrhage)
Clinical trial locations
- Belgium
- Denmark
- France
- Netherlands
- Spain
- Sweden
Study of Brain Injury and Concussion Symptoms Using Tau Tracer [18F]RO6958948 in Patients with Traumatic Brain Injury and Hemorrhages
This Swedish study uses a specialized imaging technique to understand brain injuries better. Researchers are examining patients who have experienced traumatic brain injury, intracerebral haemorrhage, or subarachnoid haemorrhage, as well as athletes with persistent symptoms from past concussions.
Main inclusion criteria: Adults aged 18-60 years with brain injuries who are stable enough to undergo a PET scan are eligible. For patients with traumatic brain injury, intracerebral haemorrhage, or subarachnoid haemorrhage, treatment in an intensive care unit is required, and family members must not object to participation. Athletes aged 18-40 with at least one previous concussion and ongoing symptoms lasting at least 6 months can also participate.
Main exclusion criteria: Patients with mild brain injury (cerebral commotio), intracerebral haemorrhage, traumatic brain injury, or subarachnoid haemorrhage are excluded from participation.
Trial focus: The study aims to determine whether a protein called tau is increased in the brains of people with these conditions compared to healthy individuals, and to identify where in the brain this increase occurs. Participants receive an injection of a special tracer and undergo a PET scan, which helps visualize tau protein in the brain. This research may lead to better understanding and treatment of brain injuries and concussions.
Investigational drug: [18F]RO6958948 is a radiopharmaceutical tracer administered through injection. It binds to tau proteins in the brain, making them visible during PET scans and helping doctors understand the extent and location of brain injury.
Study of clopidogrel and acetylsalicylic acid (aspirin) for prevention of cardiovascular events in patients who survived intracerebral hemorrhage stroke
This Dutch trial investigates whether antiplatelet medications can safely prevent future cardiovascular events in people who have survived a brain haemorrhage. The study compares taking antiplatelet medication against receiving standard care without these medications.
Main inclusion criteria: Adults aged 18 years and older who have experienced a confirmed brain haemorrhage at least 24 hours before joining the study are eligible. The brain imaging report must be available, and there must be uncertainty among doctors about the best preventive strategy. Patients must be affiliated with the Sécurité Sociale social security system.
Main exclusion criteria: People under 18 or over 65 years old cannot participate. Those unable to provide informed consent, with known allergies to antiplatelet medications, current active bleeding, pregnancy or breastfeeding, participation in other trials, life expectancy less than 6 months, recent major surgery, severe liver or kidney disease, blood clotting disorders, current use of blood thinners, planned surgery within 6 months, or severe uncontrolled high blood pressure are excluded.
Trial focus: The 60-month study monitors participants for various health events, particularly strokes, heart attacks, and other cardiovascular conditions. Researchers aim to determine whether starting antiplatelet medication is more beneficial than avoiding it in preventing future health problems. One group receives either clopidogrel (75 mg) or acetylsalicylic acid (80 mg) daily, while the other receives standard care.
Investigational drugs: Antiplatelet medications, specifically clopidogrel and acetylsalicylic acid (aspirin), are blood-thinning drugs that prevent platelets from clumping together. They are taken as tablets by mouth once daily to reduce the risk of blood clots.
Study on Avoiding Anticoagulation with Apixaban for Patients with Intracerebral Hemorrhage
This French study evaluates different treatment strategies for patients who have experienced spontaneous brain bleeding and also have atrial fibrillation, an irregular heart rhythm. The trial compares the use of blood thinners against usual care.
Main inclusion criteria: Adults aged 18 and older with documented atrial fibrillation and a CHA2DS2VASc score of 2 or more are eligible. Participants must have experienced a spontaneous brain haemorrhage confirmed by brain imaging at least 30 days before joining the study, with no upper time limit. There must be uncertainty among doctors about the best preventive strategy, and patients must be affiliated with social security.
Main exclusion criteria: Patients who have had a brain haemorrhage, are outside the specified age range, or are part of a vulnerable population requiring special protection are excluded.
Trial focus: Over 24 months, the study assesses whether direct oral anticoagulants like apixaban (Eliquis) or left atrial appendage closure procedures are effective in preventing future vascular events while balancing bleeding risks. Researchers monitor major health events, survival rates, quality of life, and use brain imaging to examine small-vessel diseases.
Investigational drugs: Direct oral anticoagulants (such as apixaban/Eliquis 2.5 mg) are blood-thinning medications taken orally that work by inhibiting specific clotting proteins. Left atrial appendage closure is a procedure rather than a medication, involving closing off a heart pouch where blood clots often form.
Study on Esketamine Hydrochloride and Sodium Chloride for Patients with Severe Acute Brain Injury
This Danish trial studies patients with severe acute brain injuries, including subarachnoid haemorrhage, intracerebral haemorrhage, or traumatic brain injury. The study investigates whether esketamine can reduce harmful brain activity waves that occur after injury.
Main inclusion criteria: Adults aged 18 years and older admitted to the Neurointensive Care Unit with severe brain injury are eligible. Patients must be scheduled for brain surgery (supratentorial craniotomy or craniectomy) and are expected to continue sedation and mechanical ventilation after surgery.
Main exclusion criteria: Patients with a history of mild brain injury (cerebral commotio), intracerebral haemorrhage, traumatic brain injury, or subarachnoid haemorrhage cannot participate.
Trial focus: The study evaluates esketamine’s effectiveness and safety in reducing cortical spreading depolarisations—waves of electrical disturbance that can worsen brain injury. Treatment lasts up to 14 days, during which researchers monitor brain activity and side effects. Six-month follow-up assessments evaluate recovery using standard scales.
Investigational drug: Esketamine (S-ketamine) is administered intravenously and works by blocking NMDA receptors in the brain. It is a dissociative anesthetic being studied for its ability to reduce harmful brain waves that can worsen injury after severe trauma or bleeding.
Study on Anakinra for Patients with Intracerebral Hemorrhage to Reduce Brain Swelling After Stroke
This Dutch study examines whether anakinra can reduce brain swelling after intracerebral haemorrhage. The medication is an anti-inflammatory drug that blocks proteins causing inflammation in the brain.
Main inclusion criteria: Adults aged 18 years and older with a confirmed non-traumatic brain haemorrhage of at least 10 mL volume are eligible. The bleeding must be in a specific part of the brain (supratentorial), not caused by aneurysms, abnormal blood vessel connections, or vein clots. Treatment must start within 8 hours of symptom onset, and informed consent is required.
Main exclusion criteria: Patients who have had recent brain bleeding, are not between 18 and 65 years old, or are part of a vulnerable population are excluded.
Trial focus: Researchers compare high-dose and low-dose anakinra against standard care, monitoring brain swelling development using MRI scans. The study also tracks side effects and measures blood markers of inflammation. Treatment is administered by injection, and health monitoring continues throughout the trial period.
Investigational drug: Anakinra is injected under the skin and works by blocking interleukin-1, a protein key to the body’s inflammatory response. By reducing inflammation, it may help prevent further brain injury after haemorrhage.
Study on the Effects of Continuing or Stopping Simvastatin and Atorvastatin in Patients with Spontaneous Lobar Intracerebral Hemorrhage
This Spanish trial investigates whether continuing or stopping cholesterol-lowering statin medications affects the risk of having another brain haemorrhage in patients who have already experienced one.
Main inclusion criteria: Adults aged 50 years and older who were taking a statin medication when they experienced a spontaneous lobar brain haemorrhage confirmed by CT or MRI are eligible. Participants must be able to start the study within 7 days of the bleeding event and agree to be randomly assigned to continue or stop taking statins.
Main exclusion criteria: Patients who have not experienced spontaneous lobar brain bleeding, are not currently taking statins, are under 18 years old, or are part of a vulnerable population are excluded.
Trial focus: Over 24 months, the study compares outcomes between those who continue and those who stop taking statins. Researchers monitor the risk of recurrent bleeding, major heart and blood vessel problems, quality of life, and cognitive functions. The study also explores genetic factors (APOE gene) that may influence bleeding risk.
Investigational drugs: Statins (simvastatin 10-40 mg or atorvastatin 10-60 mg) are cholesterol-lowering medications taken orally. They work by blocking an enzyme that produces cholesterol in the liver, helping prevent cardiovascular events while researchers assess their safety after brain bleeding.
Study on the Safety and Effects of Ixodes ricinus Contact Phase Inhibitor in Adults with Spontaneous Brain Bleeding
This Belgian study tests a new treatment called Ixodes ricinus Contact Phase Inhibitor (Ir-CPI) for spontaneous brain bleeding. The focus is on evaluating the safety and tolerability of this experimental medication.
Main inclusion criteria: Adults aged 18 years and older with first-ever spontaneous brain bleeding in a specific brain region, with blood volume between 5 and 60 mL, are eligible. Patients must have a Glasgow Coma Scale motor score of at least 5 and a Modified Rankin Scale score between 0 and 2. Written informed consent is required.
Main exclusion criteria: Patients with medical conditions other than spontaneous brain haemorrhage, those outside the specified age range, those not meeting clinical trial group criteria, and those not considered part of vulnerable populations are excluded.
Trial focus: The study evaluates how safe and tolerable Ir-CPI is when given as an intravenous infusion. Participants receive either the treatment or a placebo while researchers monitor various health indicators including adverse events, physical and neurological examinations, blood tests, and CT scans to measure changes in bleeding volume.
Investigational drug: Ir-CPI (Ixodes ricinus Contact Phase Inhibitor) is administered intravenously and is being investigated for its potential to treat spontaneous brain bleeding. Its exact mechanism of action is still under study in this Phase IIa clinical trial.
Summary
These seven trials represent diverse approaches to understanding and treating cerebral haemorrhage across multiple European countries. The Netherlands hosts two trials focusing on antiplatelet medications and anti-inflammatory approaches, while Belgium, Denmark, France, Spain, and Sweden each host one trial.
Research approaches vary considerably, from imaging studies examining brain protein accumulation to medication trials testing blood thinners, anti-inflammatory drugs, and cholesterol medications. Several studies address the complex challenge of preventing blood clots in patients who have already experienced bleeding, carefully balancing the risks of recurrent haemorrhage against the need for cardiovascular protection.
Notable is the focus on both acute treatment within hours of bleeding and long-term management strategies extending up to 60 months. Multiple trials investigate whether commonly used medications—statins, antiplatelet drugs, and anticoagulants—should be continued or stopped after brain haemorrhage, questions with significant implications for clinical practice. The trials also examine various forms of haemorrhage, including spontaneous bleeding, traumatic injury, and bleeding associated with irregular heart rhythms.