Phase
Condition
Soft Tissue Infections
Thrombocytopenia And Thrombocytopenia Prevention
Blood Clots
Treatment
BAY3389934
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant must be ≥ 18 and ≤ 80 years of age at the time of signing the informedconsent.
Participants with diagnosed sepsis according to sepsis-3 criteria. Sepsis is definedas life-threatening organ dysfunction caused by a dysregulated host response toinfection.
participants with suspected or documented origin of infection.
Participants with coagulopathy defined by at least one of the following within 24hours 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 hourswithout 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 incapableof giving informed consent, consent for study inclusion will be sought according toapplicable laws and regulations.
Exclusion
Exclusion Criteria:
Clinically significant active bleeding; known bleeding disorder, history of majortraumatic or non-traumatic bleeding (intracranial, retroperitoneal, intraocular) orclinically significant gastrointestinal bleeding within last 6 months.
Low platelets level or abnormal coagulation status due to any other reason thansepsis.
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 withpotentially clinically significant consequences due to bleeding within 28 daysbefore study drug administration.
Participants experienced neurotrauma or neurosurgery (brain, spine) or orthopedicsurgery in spine within 6 months before study drug administration
Study Design
Connect with a study center
UZ Antwerpen - Intensive Care
Edegem, 2650
BelgiumSite Not Available
Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman - Intensive Care
Liege, 4000
BelgiumSite Not Available
Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman - Intensive Care
Liège, 4000
BelgiumSite Not Available
Clinique Saint-Pierre d'Ottignies - Intensive Care
Ottignies-Louvain-la-Neuve, 1340
BelgiumActive - Recruiting
Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc - Intensive Care
Sint-Lambrechts-Woluwe, 1200
BelgiumSite Not Available
Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc - Intensive Care
Woluwe-Saint-Lambert, 1200
BelgiumSite Not Available
CHRU de Tours - Hôpital Bretonneau - Médecine Intensive Réanimation
Tours, Centre-Val de Loire 37044
FranceSite Not Available
Hopitaux Universitaires de Strasbourg Nouvel Hopital Civil - Service de Médecine Intensive Réanimation
Strasbourg, Grand Est 67091
FranceActive - Recruiting
Centre Hospitalier Universitaire de Limoges Dupuytren 1 - Service de réanimation polyvalente
Limoges, New Aquitaine 87042
FranceSite Not Available
Centre Hospitalier Universitaire d'Angers - Médecine Intensive Réanimation et Médecine Hyperbare
Angers, Pays de la Loire Region 49100
FranceSite Not Available
Centre Hospitalier Départemental Vendée - Service de réanimation polyvalente
La Roche-sur-Yon, Pays de la Loire Region 85000
FranceSite Not Available
Hopital Hotel Dieu Nantes - Service de Médecine Intensive Réanimation
Nantes, Pays de la Loire Region 44000
FranceSite Not Available
Hôpital Raymond-Poincaré - Service de Médecine Intensive - Réanimation, Médecine Hyperbare
Garches, Île-de-France Region 92380
FranceSite Not Available
Centre Hospitalier Départemental Vendée - Service de réanimation polyvalente
La Roche-Sur-Yon, 85000
FranceSite Not Available
Kliniken der Stadt Köln gGmbH - Krankenhaus Merheim - Lungenklinik
Köln, Nordrhein-Westfalen 51109
GermanySite Not Available
Kliniken der Stadt Köln gGmbH - Krankenhaus Merheim - Lungenklinik
Cologne, North Rhine-Westphalia 51109
GermanySite Not Available
Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden | Medizinische Klinik I - FB Haemostaseologie
Dresden, 01307
GermanySite Not Available
Universitätsklinikum Leipzig AöR | Interdisziplinare Internistische Intensivmedizin
Leipzig, 04103
GermanySite Not Available
Klinikum der Universität München AöR - Klinik für Anaesthesiologie (Campus Großhadern)
München, 81377
GermanySite Not Available
LMU Klinikum der Universität München Campus Innenstadt - Klink für Anaestheseologie
München, 80336
GermanySite Not Available
Canisius WIlhelmina Ziekenhuis - Intensive Care
Nijmegen, Gelderland 6532 SZ
NetherlandsSite Not Available
Universitair Medisch Centrum St. Radboud - Intensive Care
Nijmegen, Gelderland 6525 GA
NetherlandsSite Not Available
Jeroen Bosch Ziekenhuis - Intensive Care
's-Hertogenbosch, North Brabant 5223 GZ
NetherlandsSite Not Available
Medisch Spectrum Twente - Intensive Care
Enschede, Overijssel 7512 KZ
NetherlandsSite Not Available
Erasmus Medisch Centrum - Intensive Care
Rotterdam, South Holland 3015 GD
NetherlandsSite Not Available
Jeroen Bosch Ziekenhuis - Intensive Care
s-Hertogenbosch, 5223 GZ
NetherlandsSite Not Available

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