Haemorrhagic stroke Trials in Disease

Study on Eptacog Alfa for Treating Acute Hemorrhagic Stroke in Patients with Brain Bleeding

This trial is investigating a treatment called recombinant coagulation Factor VIIa (rFVIIa), also known as Eptacog Alfa, for patients who have experienced acute bleeding in the brain. The medication is a protein that helps blood to clot, which may reduce the effects of bleeding and potentially improve recovery.

Who can participate: Patients between 18 and 80 years old who have experienced spontaneous intracerebral hemorrhage (sudden bleeding inside the brain) are eligible. The study medication must be administered within 120 minutes (2 hours) from the start of the stroke or from the last time the patient was known to be well. Informed consent will be obtained according to emergency research guidelines specific to each participating country.

Who cannot participate: The trial excludes patients who have had recent surgery that could increase bleeding risk, those with severe allergic reactions to the study medication, patients currently taking blood thinners, those with known bleeding disorders, patients with severe liver disease, pregnant or breastfeeding women, patients with uncontrolled high blood pressure, those who have had a previous brain hemorrhage, patients with very low levels of consciousness, and those unable to attend follow-up visits.

What the trial involves: Participants will receive either rFVIIa or a placebo as a slow injection into a vein. The main goal is to determine if administering the medication within 2 hours of stroke onset can lead to better outcomes. Researchers will monitor participants for up to 180 days, using the modified Rankin Scale (mRS), which measures how well patients can perform daily activities and their level of disability or dependence. CT scans will be used to track changes in the volume of bleeding in the brain.

Investigational drug: The trial is testing rFVIIa, a hemostatic agent that works at the molecular level by activating the clotting process and promoting the formation of blood clots to stop bleeding. This medication is not yet widely adopted in standard medical practice for this condition, as research is ongoing to determine its effectiveness and safety.

Study on the Safety and Effects of Ixodes ricinus Contact Phase Inhibitor in Adults with Spontaneous Brain Bleeding

This Phase IIa clinical trial is testing a new treatment called Ixodes ricinus Contact Phase Inhibitor (Ir-CPI) for patients who have experienced spontaneous intracerebral hemorrhage, a type of bleeding that occurs inside the brain without any obvious external cause.

Who can participate: Adults aged 18 years or older who have experienced their first-ever spontaneous intracerebral hemorrhage in a specific part of the brain (supratentorial) with a blood volume between 5 mL and 60 mL are eligible. Patients must have a Glasgow Coma Scale best motor score of at least 5, which indicates some level of motor response and consciousness. They must also have a Modified Rankin Scale score between 0 and 2, meaning relatively low disability levels before the stroke. Written informed consent is required after understanding the study details.

Who cannot participate: Patients with medical conditions other than spontaneous intracerebral hemorrhage, those outside the specified age range, individuals not fitting the specific clinical trial groups, and those considered part of vulnerable populations are excluded from participation.

What the trial involves: The main goal is to evaluate how safe and tolerable Ir-CPI is for patients with this type of brain bleed. Participants will receive either the new treatment or a placebo as an infusion directly into the bloodstream. Throughout the study, researchers will conduct regular physical and neurological examinations, perform blood tests to assess biochemistry and blood clotting levels, and use CT scans to measure changes in the volume of the hemorrhage. The study will monitor participants for any adverse events or side effects to ensure their safety.

Investigational drug: Ir-CPI is administered as a solution for infusion and is currently being studied to understand if it can help patients who experience spontaneous brain bleeding. The medication is being explored for its potential therapeutic benefits in neurology, specifically for conditions involving brain hemorrhages. As this is an early-stage trial, researchers are working to determine its safety profile and effectiveness.

Summary

Both ongoing clinical trials for haemorrhagic stroke are focused on developing treatments that can help stop bleeding in the brain and improve patient outcomes. The trials are concentrated in European countries, including Germany, Spain, and Belgium, reflecting a regional effort to advance stroke treatment options.

The two trials are testing different approaches: one uses rFVIIa, a clotting protein that has been studied in various bleeding conditions, while the other investigates Ir-CPI, a newer investigational medication. Both studies emphasize the importance of rapid treatment, with the rFVIIa trial specifically requiring medication administration within 2 hours of stroke onset. The trials use similar outcome measures, particularly the modified Rankin Scale, to assess disability and recovery levels over several months. These studies represent important steps in finding new ways to treat this serious and often devastating condition.