A Study to Learn About How Safe BAY 3389934 is, Its Suitable Dose, and How it Affects the Participants With Sepsis Induced Coagulopathy

Launched by BAYER · Feb 28, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called BAY 3389934 for patients who have sepsis induced coagulopathy, a serious condition where the body’s response to infection leads to problems with blood clotting. The main goal of the study is to find out how safe this medication is, what the right dose should be, and how it affects patients in the hospital’s intensive care unit (ICU). Researchers will monitor participants for any health issues that may arise during the trial, even if they are not directly related to the medication.

To be eligible for the study, participants must be at least 18 years old and have a confirmed diagnosis of sepsis along with specific blood clotting issues. The trial will involve around 28 days of monitoring, where doctors will conduct physical exams, take blood and urine samples, check vital signs, and assess heart health. Participants will be divided into groups, with each group receiving different doses of the medication. The study is currently recruiting, and it’s important for potential participants to discuss any concerns with their healthcare team.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Participant must be ≥ 18 years of age at the time of signing the informed consent.
• • Participants with diagnosed sepsis according to sepsis-3 criteria. Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection.
• • participants with suspected or documented origin of infection.
• • Participants with coagulopathy defined by at least one of the following within 24 hours prior start of study intervention: INR ≥1.40, platelet count in the range of ≥ 30,000/mm3 to \< 150,000/mm3 OR greater than 30% decrease in platelets in 24 hours without other known etiology. The platelet count after decrease should not be \< 30,000/mm3.
• • Participants must be receiving treatment in an ICU.
• • Informed consent of capable participant or, in case of participant being incapable of giving informed consent, consent for study inclusion will be sought according to applicable laws and regulations.
• Exclusion Criteria:
• • Clinically significant active bleeding; known bleeding disorder, history of major traumatic or non-traumatic bleeding (intracranial, retroperitoneal, intraocular) or clinically significant gastrointestinal bleeding within last 6 months.
• • Low platelets level or abnormal coagulation status due to any other reason than sepsis.
• • Participants with indication for therapeutic dose of: anticoagulation (heparin, argatroban, vitamin K antagonists/warfarin, dabigatran, apixaban, rivaroxaban, edoxaban), oral antiplatelet agents (clopidogrel, ticagrelor, ticlopidine, prasugrel) except low dose (≤100mg) acetyl salicylic acid (ASA), digoxin
• • Active malignancy
• • Pregnancy or breastfeeding.
• • Chronic liver disease Child-Pugh Class C.
• • Participants experienced major surgery or major trauma (intrathoracic, intra-abdominal, pelvic or femur) or surgery/trauma in any other area with potentially clinically significant consequences due to bleeding within 28 days before study drug administration.
• • Participants experienced neurotrauma or neurosurgery (brain, spine) or orthopedic surgery in spine within 6 months before study drug administration