Status:

RECRUITING

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

Lead Sponsor:

Bayer

Conditions:

Sepsis

Coagulopathy

Eligibility:

All Genders

18-80 years

Phase:

PHASE1

Brief Summary

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...

Eligibility Criteria

Inclusion Criteria:

  • Participant must be ≥ 18 and ≤ 80 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, metformin
  • Any 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

Key Trial Info

Start Date :

March 12 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

February 28 2027

Estimated Enrollment :

36 Patients enrolled

Trial Details

Trial ID

NCT06854640

Start Date

March 12 2025

End Date

February 28 2027

Last Update

March 27 2026

Active Locations (20)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 5 (20 locations)

1

UZ Antwerpen - Intensive Care

Edegem, Belgium, 2650

2

Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman - Intensive Care

Liège, Belgium, 4000

3

Clinique Saint-Pierre d'Ottignies - Intensive Care

Ottignies-Louvain-la-Neuve, Belgium, 1340

4

Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc - Intensive Care

Woluwe-Saint-Lambert, Belgium, 1200

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