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 equally divided into different groups. The first group will receive the lowest dose of BAY 3389934. If researchers consider this dose to be safe, the next group of participants will receive a higher dose until the researchers find a suitable dose of BAY 3389934. 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
32
Solution for IV infusion
UZ Antwerpen - Intensive Care
Edegem, Belgium
Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman - Intensive Care
Liège, Belgium
Clinique Saint-Pierre d'Ottignies - Intensive Care
Ottignies-Louvain-la-Neuve, Belgium
Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc - Intensive Care
Woluwe-Saint-Lambert, Belgium
Centre Hospitalier Universitaire d'Angers - Médecine Intensive Réanimation et Médecine Hyperbare
Angers, France
Hôpital Raymond-Poincaré - Service de Médecine Intensive - Réanimation, Médecine Hyperbare
Garches, France
Centre Hospitalier Départemental Vendée - Service de réanimation polyvalente
La Roche-sur-Yon, France
Centre Hospitalier Universitaire de Limoges Dupuytren 1 - Service de réanimation polyvalente
Limoges, France
Hopital Hotel Dieu Nantes - Service de Médecine Intensive Réanimation
Nantes, France
Hopitaux Universitaires de Strasbourg Nouvel Hopital Civil - Service de Médecine Intensive Réanimation
Strasbourg, France
...and 10 more locations
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
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