Actively Recruiting
A Study to Learn About How Safe BAY 3389934 is, Its Suitable Dose, and How it Affects the Participants With Sepsis Induced Coagulopathy
Led by Bayer · Updated on 2026-04-22
36
Participants Needed
20
Research Sites
100 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
A Study to Learn About How Safe BAY 3389934 is, Its Suitable Dose, and How it Affects the Participants With Sepsis Induced Coagulopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 18 to 80 years at the time of consent
- Diagnosed with sepsis according to sepsis-3 criteria
- Suspected or documented source of infection
- Coagulopathy defined by INR 61.40, platelet count between 61 30,000/mm3 and <150,000/mm3, or a >30% decrease in platelets within 24 hours without other cause
- Receiving treatment in an intensive care unit (ICU)
- Informed consent given by participant or legal representative according to laws and regulations
You will not qualify if you...
- Clinically significant active bleeding or history of major bleeding (intracranial, retroperitoneal, intraocular, or gastrointestinal) within past 6 months
- Low platelets or abnormal coagulation due to causes other than sepsis
- Need for therapeutic doses of anticoagulants or certain oral antiplatelet agents except low dose aspirin (up to 100 mg)
- Use of digoxin or metformin
- Any active cancer
- Pregnancy or breastfeeding
- Chronic liver disease classified as Child-Pugh Class C
- Major surgery or trauma with bleeding risk within 28 days before study drug administration
- Neurotrauma, neurosurgery, or spine orthopedic surgery within 6 months before study drug administration
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 20 locations
1
UZ Antwerpen - Intensive Care
Edegem, Belgium, 2650
Not Yet Recruiting
2
Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman - Intensive Care
Liège, Belgium, 4000
Not Yet Recruiting
3
Clinique Saint-Pierre d'Ottignies - Intensive Care
Ottignies-Louvain-la-Neuve, Belgium, 1340
Actively Recruiting
4
Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc - Intensive Care
Woluwe-Saint-Lambert, Belgium, 1200
Not Yet Recruiting
5
CHRU de Tours - Hôpital Bretonneau - Médecine Intensive Réanimation
Tours, Centre-Val de Loire, France, 37044
Not Yet Recruiting
6
Hopitaux Universitaires de Strasbourg Nouvel Hopital Civil - Service de Médecine Intensive Réanimation
Strasbourg, Grand Est, France, 67091
Actively Recruiting
7
Centre Hospitalier Universitaire de Limoges Dupuytren 1 - Service de réanimation polyvalente
Limoges, New Aquitaine, France, 87042
Not Yet Recruiting
8
Centre Hospitalier Universitaire d'Angers - Médecine Intensive Réanimation et Médecine Hyperbare
Angers, Pays de la Loire Region, France, 49100
Not Yet Recruiting
9
Centre Hospitalier Départemental Vendée - Service de réanimation polyvalente
La Roche-sur-Yon, Pays de la Loire Region, France, 85000
Not Yet Recruiting
10
Hopital Hotel Dieu Nantes - Service de Médecine Intensive Réanimation
Nantes, Pays de la Loire Region, France, 44000
Not Yet Recruiting
11
Hôpital Raymond-Poincaré - Service de Médecine Intensive - Réanimation, Médecine Hyperbare
Garches, Île-de-France Region, France, 92380
Not Yet Recruiting
12
Kliniken der Stadt Köln gGmbH - Krankenhaus Merheim - Lungenklinik
Cologne, North Rhine-Westphalia, Germany, 51109
Not Yet Recruiting
13
Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden | Medizinische Klinik I - FB Haemostaseologie
Dresden, Germany, 01307
Not Yet Recruiting
14
Universitätsklinikum Leipzig AöR | Interdisziplinare Internistische Intensivmedizin
Leipzig, Germany, 04103
Not Yet Recruiting
15
Klinikum der Universität München AöR - Klinik für Anaesthesiologie (Campus Großhadern)
München, Germany, 81377
Not Yet Recruiting
16
Universitair Medisch Centrum St. Radboud - Intensive Care
Nijmegen, Gelderland, Netherlands, 6525 GA
Not Yet Recruiting
17
Canisius WIlhelmina Ziekenhuis - Intensive Care
Nijmegen, Gelderland, Netherlands, 6532 SZ
Not Yet Recruiting
18
Jeroen Bosch Ziekenhuis - Intensive Care
's-Hertogenbosch, North Brabant, Netherlands, 5223 GZ
Not Yet Recruiting
19
Medisch Spectrum Twente - Intensive Care
Enschede, Overijssel, Netherlands, 7512 KZ
Not Yet Recruiting
20
Erasmus Medisch Centrum - Intensive Care
Rotterdam, South Holland, Netherlands, 3015 GD
Not Yet Recruiting
Research Team
B
Bayer Clinical Trials Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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