Researchers are looking for a better way to treat people who have sepsis induced coagulopathy. Sepsis happens when bacteria and their toxins spread in the blood, causing an infection. To overcome the infection the body responds activating the immune system, sometimes this immune response is too active and causes uncontrolled blood clot formation, also called sepsis-induced coagulopathy. Sepsis coagulopathy damages blood vessels and organs and leads to low platelet levels in the body. In severe cases, it can even lead to death. The main purpose of this first in patient study is to learn about how safe BAY 3389934 is, its suitable dose, and how it affects the participants with sepsis induced coagulopathy. For this study, researchers will enroll people receiving treatment for sepsis induced coagulopathy in a hospital intensive care unit (ICU). For this, the researchers will collect the number of participants with medical problems during and after receiving BAY 3389934. These medical problems are also known as "adverse events". Doctors keep track of all medical problems that happen in studies, even if they do not think they might be related to the study treatments. Participants will be divided into 2 groups. The first group will receive the lowest starting dose of BAY3389934. The researcher will carefully monitor how the participant responds to the medication and may adjust the dose, either increasing or decreasing it based on the safety and the tolerability of the drug. If no serious side effects are reported from the first group, the second group will receive higher dose of BAY3389934. Each participant will be in the study for around 28 days. During the study, the doctors and their study team will: * Take blood and urine samples, * Do physical examinations, * Check vital signs such as body temperature, blood pressure and heart rate, * Examine heart health using electrocardiogram (ECG)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
36
Solution for IV infusion
UZ Antwerpen - Intensive Care
Edegem, Belgium
NOT_YET_RECRUITINGCentre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman - Intensive Care
Liège, Belgium
NOT_YET_RECRUITINGClinique Saint-Pierre d'Ottignies - Intensive Care
Ottignies-Louvain-la-Neuve, Belgium
RECRUITINGUniversite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc - Intensive Care
Woluwe-Saint-Lambert, Belgium
The number of participants with TEAEs (treatment-emergent adverse events)
Time frame: After the first administration of study intervention to 1 hour after stop from study intervention, up to 97 hours
Severity of TEAEs
Time frame: After the first administration of study intervention to 1 hour after stop from study intervention, up to 97 hours
Activated partial thromboplastin time (aPTT)
Time frame: From the first administration of study intervention day 1 to day 6
Prothrombin time (PT)
Time frame: From the first administration of study intervention day 1 to day 6
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
CHRU de Tours - Hôpital Bretonneau - Médecine Intensive Réanimation
Tours, Centre-Val de Loire, France
NOT_YET_RECRUITINGHopitaux Universitaires de Strasbourg Nouvel Hopital Civil - Service de Médecine Intensive Réanimation
Strasbourg, Grand Est, France
RECRUITINGCentre Hospitalier Universitaire de Limoges Dupuytren 1 - Service de réanimation polyvalente
Limoges, New Aquitaine, France
NOT_YET_RECRUITINGCentre Hospitalier Universitaire d'Angers - Médecine Intensive Réanimation et Médecine Hyperbare
Angers, Pays de la Loire Region, France
NOT_YET_RECRUITINGCentre Hospitalier Départemental Vendée - Service de réanimation polyvalente
La Roche-sur-Yon, Pays de la Loire Region, France
NOT_YET_RECRUITINGHopital Hotel Dieu Nantes - Service de Médecine Intensive Réanimation
Nantes, Pays de la Loire Region, France
NOT_YET_RECRUITING...and 10 more locations