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)
| Facility | City | Region | Status |
|---|---|---|---|
| UC Health University of Colorado Hospital - Medical Intensive Care Unit | Aurora | Colorado | Not Yet Recruiting |
| UZ Antwerpen - Intensive Care | Edegem | Antwerp | Not Yet Recruiting |
| Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc - Intensive Care | Woluwe-Saint-Lambert | Brussels Capital | Not Yet Recruiting |
| Clinique Saint-Pierre d'Ottignies - Intensive Care | Ottignies | Walloon Brabant | Recruiting |
| Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman - Intensive Care | Liège | Belgium | Recruiting |
| CHRU de Tours - Hôpital Bretonneau - Médecine Intensive Réanimation | Tours | Centre-Val de Loire | Not Yet Recruiting |
| Hopitaux Universitaires de Strasbourg Nouvel Hopital Civil - Service de Médecine Intensive Réanimation | Strasbourg | Grand Est | Recruiting |
| Centre Hospitalier Universitaire de Limoges Dupuytren 1 - Service de réanimation polyvalente | Limoges | New Aquitaine | Recruiting |
| Centre Hospitalier Universitaire d'Angers - Médecine Intensive Réanimation et Médecine Hyperbare | Angers | Pays de la Loire Region | Recruiting |
| Centre Hospitalier Départemental Vendée - Service de réanimation polyvalente | La Roche-sur-Yon | Pays de la Loire Region | Recruiting |
| Hopital Hotel Dieu Nantes - Service de Médecine Intensive Réanimation | Nantes | Pays de la Loire Region | Recruiting |
| Hôpital Raymond-Poincaré - Service de Médecine Intensive - Réanimation, Médecine Hyperbare | Garches | Île-de-France Region | Not Yet Recruiting |
| Klinikum der Universität München AöR - Klinik für Anaesthesiologie (Campus Großhadern) | München | Bavaria | Not Yet Recruiting |
| Kliniken der Stadt Köln gGmbH - Krankenhaus Merheim - Lungenklinik | Cologne | North Rhine-Westphalia | Not Yet Recruiting |
| Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden | Medizinische Klinik I - FB Haemostaseologie | Dresden | Saxony | Recruiting |
| Universitätsklinikum Leipzig AöR_Interdisziplinare Internistische Intensivmedizin | Leipzig | Saxony | Not Yet Recruiting |
| Universitair Medisch Centrum St. Radboud - Intensive Care | Nijmegen | Gelderland | Not Yet Recruiting |
| Canisius WIlhelmina Ziekenhuis - Intensive Care | Nijmegen | Gelderland | Not Yet Recruiting |
| Jeroen Bosch Ziekenhuis - Intensive Care | 's-Hertogenbosch | North Brabant | Not Yet Recruiting |
| Medisch Spectrum Twente - Intensive Care | Enschede | Overijssel | Not Yet Recruiting |
| Erasmus Medisch Centrum - Intensive Care | Rotterdam | South Holland | Not Yet Recruiting |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06854640 on ClinicalTrials.gov ↗ ← All trials in the USA