An Observational Study to Learn About the Occurrence of Disseminated Intravascular Coagulation Among Adults With Sepsis in Japan

Active, not recruiting

• Conditions: Sepsis; Disseminated Intravascular Coagulation

• Registration Number: NCT06373159
• Lead Sponsor: Bayer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-3-25
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 5740

Inclusion Criteria

Inclusion Criteria:<br><br> - Sepsis patient cohort<br><br> - Sepsis patients<br><br> - Age =18 years<br><br> - Subgroups:<br><br> - Sepsis with thrombocytopenia patient cohort<br><br> - Septic shock patient cohort<br><br> - Sepsis-associated DIC patient cohort<br><br> - DIC patients in sepsis patient cohort<br><br> - Subgroups:<br><br> - Organ failure: kidney (Serum creatinine (SCr) < 1.2 mg/dl and = 1.2 mg/dl)<br><br> - Organ failure: liver (bilirubin < 1.2 mg/dl and = 1.2 mg/dl)<br><br> - Organ failure: cardiovascular (with and without catecholamine or<br> vasopressin)<br><br> - With low molecular weight (LMW) heparins, unfractionated heparins, and<br> both<br><br> - With and without DIC treatment<br><br> - Priority 1_Anticoagulants specifically used in Japan (recombinant<br> antithrombin, recombinant thrombomodulin, human anti-thrombin III)<br><br> - Priority 1 + Priority 2_Drugs for sepsis-associated DIC (LMW<br> heparins, unfractionated heparins, protease inhibitors)<br><br> - Priority 1 + Priority 2 + Priority 3_antibiotics (antifungals),<br> and/or steroids<br><br> - Non-sepsis-associated DIC patient cohort<br><br> - Hematopoietic malignant tumor patients<br><br> - DIC patients<br><br> - Age =18 years<br><br>Exclusion Criteria:<br><br> - Sepsis patient cohort: None<br><br> - Sepsis-associated DIC patient cohort: None<br><br> - Non-sepsis-associated DIC patient cohort: Sepsis patients

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of DIC assessed at 14 days, 21 days and 28 days of the patient follow up;Distribution of JAAM DIC score;Distribution of ISTH DIC score;Distribution of MHLW DIC score;Distribution of SOFA score;Days from sepsis diagnosis to the onset of DIC

Secondary Outcome Measures

Name	Time	Method
Number of participants per clinical characteristics;Number of participants per DIC treatment patterns in patients with sepsis-associated DIC following the onset of DIC;Incidence rates of clinical outcomes assessed in patients with sepsis-associated DIC;Cumulative incidences of clinical outcomes assessed in patients with sepsis-associated DIC;Number of participants per clinical characteristics in subgroup of patients who developed sepsis-associated DIC;Number of participants per treatment patterns in subgroup of patients who developed sepsis-associated DIC;Incidence rates of clinical outcomes in subgroup of patients who developed sepsis-associated DIC;Number of participants per clinical characteristics after the onset of DIC in patients with non-sepsis-associated DIC;Number of participants per treatment patterns after the onset of DIC in patients with non-sepsis-associated DIC;Incidence rates of clinical outcomes after the onset of DIC in patients with non-sepsis-associated DIC