Ongoing Clinical Trials for Cerebral Haemorrhage
There are currently 7 clinical trials studying new treatments and approaches for cerebral haemorrhage (also known as brain haemorrhage, intracerebral hemorrhage, brain bleeding). These trials are taking place across Europe, investigating medications, imaging techniques, and treatment strategies aimed at improving outcomes for patients who have experienced bleeding in the brain.
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 trial is investigating brain injuries using a special imaging technique called positron emission tomography (PET) scanning. The study focuses on patients with traumatic brain injury, intracerebral hemorrhage, and subarachnoid hemorrhage, as well as athletes with persistent concussion symptoms.
Main inclusion criteria: Participants must be between 18 and 60 years old and stable enough to undergo a PET scan. Patients with brain injuries must have been treated in intensive care with family consent. Athletes aged 18-40 must have experienced at least one concussion with symptoms lasting at least 6 months.
Main exclusion criteria: The study excludes individuals with cerebral commotio (mild brain injury), intracerebral hemorrhage, traumatic brain injury, or subarachnoid hemorrhage who do not meet the specific inclusion requirements.
Focus and goal: The study aims to determine whether tau protein levels are increased in the brains of people with these conditions compared to those without brain injuries, and to identify where in the brain this increase occurs. This information could lead to better understanding and treatment of brain injuries and concussions.
Investigational drug: The study uses [18F]RO6958948, a tau tracer administered as an injection. This substance helps make tau protein visible during PET scans, allowing researchers to observe its presence and location in the brain.
Study of clopidogrel and acetylsalicylic acid (aspirin) for prevention of cardiovascular events in patients who survived intracerebral hemorrhage stroke
This Netherlands-based trial examines whether starting antiplatelet therapy is beneficial for people who have survived a brain hemorrhage. The study will run from April 2025 to April 2029.
Main inclusion criteria: Participants must be at least 18 years old and have experienced a stroke caused by brain bleeding confirmed by brain imaging at least 24 hours before joining the study. The brain imaging report must be available for review.
Main exclusion criteria: Individuals outside the age range of 18-65 years, those unable to provide informed consent, people with known allergies to antiplatelet medications, current active bleeding, pregnancy or breastfeeding, severe liver disease or kidney failure requiring dialysis, and those with severe uncontrolled high blood pressure are excluded.
Focus and goal: The research aims to determine whether taking oral antiplatelet medication is more beneficial than avoiding these medications in preventing future cardiovascular and brain-related health events. The study monitors patients for strokes, heart attacks, and other cardiovascular conditions over 60 months.
Investigational drugs: Participants receive either clopidogrel (75 mg daily) or acetylsalicylic acid (80 mg daily), which are antiplatelet medications that help prevent blood clots from forming. These are taken as tablets by mouth once daily.
Study on Avoiding Anticoagulation with Apixaban for Patients with Intracerebral Hemorrhage
This French study evaluates treatment strategies for patients who have experienced spontaneous bleeding in the brain and have a history of atrial fibrillation, an irregular heart rhythm. The trial compares different approaches including the use of blood thinners.
Main inclusion criteria: Adults over 18 years old with documented atrial fibrillation on an electrocardiogram, a CHA2DS2VASc score of 2 or more (indicating need for blood-thinning medication), and a spontaneous brain hemorrhage confirmed by brain imaging that occurred more than 30 days before joining the study. Patients must be affiliated with the French social security system.
Main exclusion criteria: The study excludes patients with recent brain hemorrhage, those outside the specified age range, and members of vulnerable populations.
Focus and goal: The study aims to assess the effectiveness of different treatment strategies in preventing future vascular events while balancing the risk of further bleeding. Researchers will monitor various outcomes over 24 months, including major vascular events, overall survival, and quality of life.
Investigational drugs: The study involves Eliquis (apixaban) 2.5 mg film-coated tablets, a type of direct oral anticoagulant. The trial also examines Left Atrial Appendage Closure (LAAC), a medical procedure rather than a medication, which aims to prevent blood clots by closing off a specific area of the heart.
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 hemorrhage, intracerebral hemorrhage, and traumatic brain injury. The research focuses on a specific type of brain activity that can worsen injury outcomes.
Main inclusion criteria: Patients must be 18 years or older, admitted to the Neurointensive Care Unit with one of the specified brain injuries, planned for brain surgery (supratentorial craniotomy or craniectomy), and expected to continue sedation and mechanical ventilation after surgery.
Main exclusion criteria: Individuals with a history of subarachnoid hemorrhage, intracerebral hemorrhage, or traumatic brain injury who do not meet the specific inclusion criteria cannot participate.
Focus and goal: The study investigates whether Esketamine Hydrochloride can reduce the occurrence of cortical spreading depolarisations, which are waves of electrical activity that can spread across the brain and worsen injury. The treatment period lasts up to 14 days, with follow-up assessments at six months to evaluate recovery and functional abilities.
Investigational drugs: S-ketamine (esketamine hydrochloride) is administered through infusion directly into the bloodstream. It works by blocking NMDA receptors in the brain, which are involved in the development of harmful brain wave patterns after injury.
Study on Anakinra for Patients with Intracerebral Hemorrhage to Reduce Brain Swelling After Stroke
This Netherlands trial focuses on reducing brain swelling following intracerebral hemorrhage. The study compares different doses of anakinra to standard medical care.
Main inclusion criteria: Participants must be at least 18 years old with a confirmed supratentorial non-traumatic intracerebral hemorrhage of at least 10 mL volume, verified by CT scan. The CT scan must not show other causes of bleeding such as aneurysms or abnormal blood vessel connections. Treatment must begin within 8 hours of symptom onset, and informed consent must be provided.
Main exclusion criteria: The study excludes patients with recent brain hemorrhage, those not within the age range of 18-65 years, and members of vulnerable populations.
Focus and goal: The research aims to understand how different doses of anakinra affect brain swelling development after stroke. The study monitors brain swelling using MRI scans and tracks side effects and inflammatory blood markers. The trial is expected to conclude by September 2025.
Investigational drugs: Anakinra is administered as an injection under the skin. It works by blocking interleukin-1, a protein that plays a key role in the body’s inflammatory response, potentially helping to reduce brain swelling and prevent further injury after a stroke.
Study on the Effects of Continuing or Stopping Simvastatin and Atorvastatin in Patients with Spontaneous Lobar Intracerebral Hemorrhage
This Spanish study examines the effects of statins, cholesterol-lowering medications, in patients who have experienced a specific type of brain hemorrhage. The research addresses the important question of whether to continue or stop these commonly prescribed medications after a brain bleed.
Main inclusion criteria: Participants must be 50 years or older with a spontaneous lobar intracerebral hemorrhage confirmed by CT or MRI scan. They must have been taking a statin medication at the time of the hemorrhage and be able to start the study within 7 days of the bleeding event. Participants must agree to be randomly assigned to either continue or stop taking statins.
Main exclusion criteria: The study excludes patients who have not experienced a spontaneous lobar brain hemorrhage, those not currently taking statins, individuals under 18 years old, and members of vulnerable populations.
Focus and goal: The study aims to understand the impact of continuing versus stopping statin use on the risk of having another brain hemorrhage and on major heart and blood vessel problems. Participants are monitored over 24 months, with assessments of quality of life and cognitive functions. The research also explores the role of genetic factors, specifically the APOE gene, in recurrence risk.
Investigational drugs: The study involves various doses of simvastatin (10 mg, 20 mg, or 40 mg) and atorvastatin (10 mg, 20 mg, 40 mg, or 60 mg), all taken orally as film-coated tablets. These medications work by inhibiting HMG-CoA reductase, an enzyme crucial for cholesterol production in the liver.
Study on the Safety and Effects of Ixodes ricinus Contact Phase Inhibitor in Adults with Spontaneous Brain Bleeding
This Belgian trial tests a new treatment called Ixodes ricinus Contact Phase Inhibitor (Ir-CPI) for patients with spontaneous bleeding inside the brain. The study is designed to evaluate safety and tolerability of this novel approach.
Main inclusion criteria: Participants must be at least 18 years old and provide written informed consent. They must have a first-ever spontaneous, supratentorial intracerebral hemorrhage with a blood volume between 5 mL and 60 mL. Patients must have a Glasgow Coma Scale best motor score of at least 5 (indicating some motor response) and a Modified Rankin Scale score between 0 and 2 (indicating minimal disability).
Main exclusion criteria: Patients with medical conditions other than spontaneous intracerebral hemorrhage, those outside the specified age range, individuals not part of the specified clinical trial groups, and those not considered part of vulnerable populations are excluded.
Focus and goal: The main goal is to evaluate how safe and tolerable Ir-CPI is for patients who have experienced spontaneous brain bleeding. The study monitors various health indicators including adverse events, physical and neurological examinations, blood tests to assess biochemistry and coagulation, and CT scans to measure changes in hemorrhage volume.
Investigational drugs: Ir-CPI is administered as a solution through an infusion directly into the veins. This Phase IIa clinical trial is exploring its potential therapeutic benefits for brain hemorrhages, though its exact mechanism of action at the molecular level is still under investigation.
Summary
The seven ongoing clinical trials for cerebral haemorrhage reflect diverse approaches to managing this serious condition. The trials are spread across six European countries, with the Netherlands hosting two studies and Belgium, Denmark, France, Spain, and Sweden each hosting one trial.
Several notable themes emerge from these studies. Multiple trials focus on anticoagulation and antiplatelet therapy, addressing the complex challenge of preventing blood clots while managing bleeding risk. The Netherlands and France are both studying whether blood-thinning medications are safe and beneficial after brain hemorrhage, while the Spanish trial specifically examines statin medications.
Another important focus area is reducing secondary brain injury. The Netherlands and Denmark trials investigate medications (anakinra and esketamine, respectively) aimed at reducing brain swelling and harmful brain activity patterns following hemorrhage. Meanwhile, the Belgian trial is testing a completely novel agent, Ir-CPI, for treating spontaneous brain bleeding.
The Swedish trial takes a different approach, using advanced imaging to understand brain injury mechanisms by visualizing tau protein accumulation. This diagnostic focus could provide insights into long-term consequences of brain hemorrhage.
These trials represent important steps toward improving outcomes for patients with cerebral haemorrhage, addressing prevention of recurrent events, reduction of secondary injury, and better understanding of the underlying disease processes.
