do_not_disturb_altRecruitment Complete
Sepsis, Disseminated intravascular coagulation
Bayer Identifier:infoA unique number for a trial given by Bayer.
22643
ClinicalTrials.gov Identifier:infoA unique number for a trial given by United States government.
EudraCT Number:infoA unique reference for a trial given by European medical agency.
Not Available
EU CT Number:infoA unique reference for a trial given by European medical agency under EU Clinical Trial Regulation
Not Available
An Observational Study to Learn About the Occurrence of Disseminated Intravascular Coagulation Among Adults with Sepsis in Japan
Trial purpose
This is an observational study in which data already collected from people with sepsis (blood poisoning) and/or disseminated intravascular coagulation (DIC) are studied.
In observational studies, only observations are made without participants receiving any advice or changes to their healthcare.
DIC is a serious blood disorder that can cause clots throughout the body, blocking blood vessels. People who have sepsis or cancer are at a higher risk of developing DIC.
To find a treatment that works well for people with DIC associated with sepsis, it is important to know about its occurrence, treatments people receive, and their outcomes. Japan is the only country that has officially approved medicines for DIC including a few newer medicines that prevent extensive blood clotting.
In this study, researchers will assess patient data from a hospital database in Japan.
The main purpose of this study is to learn more about how many adults develop DIC related to sepsis, thrombocytopenic sepsis (sudden decrease in the number of platelets in the blood), or septic shock (dangerously low blood pressure) in Japan every year.
To learn about this, researchers will collect the following information:
- The number of participants who developed DIC 14 days, 21 days and 28 days after their sepsis diagnosis
- The grading scores given to the participants which are used to assess the likelihood, cause, severity, treatment plan, and outcome of DIC (including scores called JAAM, ISTH, MHLW, and/or SOFA scores)
- The number of days between diagnosis of sepsis and the beginning of DIC
Researchers will study the data collected between June 2018 and June 2023.
The data will come from TXP Medical, which collects data through the hospital health information system of 7 selected hospitals for this study across Japan.
In this study, only available data from routine care are collected.
In observational studies, only observations are made without participants receiving any advice or changes to their healthcare.
DIC is a serious blood disorder that can cause clots throughout the body, blocking blood vessels. People who have sepsis or cancer are at a higher risk of developing DIC.
To find a treatment that works well for people with DIC associated with sepsis, it is important to know about its occurrence, treatments people receive, and their outcomes. Japan is the only country that has officially approved medicines for DIC including a few newer medicines that prevent extensive blood clotting.
In this study, researchers will assess patient data from a hospital database in Japan.
The main purpose of this study is to learn more about how many adults develop DIC related to sepsis, thrombocytopenic sepsis (sudden decrease in the number of platelets in the blood), or septic shock (dangerously low blood pressure) in Japan every year.
To learn about this, researchers will collect the following information:
- The number of participants who developed DIC 14 days, 21 days and 28 days after their sepsis diagnosis
- The grading scores given to the participants which are used to assess the likelihood, cause, severity, treatment plan, and outcome of DIC (including scores called JAAM, ISTH, MHLW, and/or SOFA scores)
- The number of days between diagnosis of sepsis and the beginning of DIC
Researchers will study the data collected between June 2018 and June 2023.
The data will come from TXP Medical, which collects data through the hospital health information system of 7 selected hospitals for this study across Japan.
In this study, only available data from routine care are collected.
Key Participants Requirements
Sex
AllAge
18 - N/ATrial summary
Enrollment Goal info
5740The overall number of participants needed for a trial.
Trial Dates info
March 2024 - December 2025Trial dates are when the trial starts and ends. If they are in the future, then they are estimates and can change before or during a trial.
Phase info
N/AA phase is a step in the research of a new treatment.
Could I Receive a placebo info
NoA “placebo” looks like a treatment but usually does not have any real treatment. A placebo is used to make sure the effects of a treatment that are seen in a trial are actually caused by that treatment.
Products info
No DrugA “product” can be any kind of drug, medical device, vaccine, or other treatment that is being studied in a trial.
Accepts Healthy Volunteer info
NoA healthy volunteer is a person who takes part in a trial but does not have a disease or condition. Usually, healthy volunteers are in Phase 1 trials.
Where to participate
| Status | Institution | Location |
|---|---|---|
Active, not recruiting | Bayer | Tokyo, 100-8265, Japan |
Primary OutcomeinfoA primary outcome is the most important effect of a treatment that is measured in a trial. Most trials have one primary outcome measure, but some have more than one.
- Incidence of DIC assessed at 14 days, 21 days and 28 days of the patient follow upDIC: disseminated intravascular coagulationdate_rangeTime Frame:Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
- Distribution of JAAM DIC scoreThe Japanese Association for Acute Medicine (JAAM) DIC scoring algorithm includes a number of variables but in addition specific criteria for evidence of a Systemic Inflammatory Response Syndrome (SIRS). JAAM DIC score >= 4 supports a diagnosis of DIC. DIC: disseminated intravascular coagulationdate_rangeTime Frame:Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
- Distribution of ISTH DIC scoreThe International Society on Thrombosis Haemostasis (ISTH) DIC score is a simple scoring system produced by the ISTH group for the diagnosis of DIC depending on the Platelet count, the PT, the fibrinogen level and critically the FDP/D-Dimer results. A total score of ≥5 = DIC as long as the score is associated with a clinical disorder known to cause DIC. DIC: disseminated intravascular coagulationdate_rangeTime Frame:Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
- Distribution of MHLW DIC scoreThe Japanese Ministry of Health, Labor and Welfare (MHLW) DIC score is a scoring system for the diagnosis of overt DIC. MHLW DIC score ≥7 is defined as DIC. DIC: disseminated intravascular coagulationdate_rangeTime Frame:Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
- Distribution of SOFA scoreThe Sequential Organ Failure Assessment (SOFA) score is a scoring system based on performance of respiratory, coagulation, liver, cardiovascular, central nervous system, and kidney. The higher the SOFA score, the higher the likely mortality. DIC: disseminated intravascular coagulationdate_rangeTime Frame:Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
- Days from sepsis diagnosis to the onset of DICDIC: disseminated intravascular coagulationdate_rangeTime Frame:Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
Secondary OutcomeinfoA secondary outcome is an effect of a treatment that is measured in a trial. A secondary outcome is less important than a primary outcome. But secondary outcomes are still important since they help researchers learn more about the effects of a treatment. Most clinical trials have more than one secondary outcome measure.
- Number of participants per clinical characteristicsClinical characteristics (e.g., demographics, comorbidities, medical history) in patients with sepsis, thrombocytopenic sepsis and septic shock, respectively; in patients with sepsis in different definitions (diagnosis codes, laboratory values, and procedure codes); at the onset of DIC in patients who developed sepsis-associated DIC. DIC: disseminated intravascular coagulationdate_rangeTime Frame:Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
- Number of participants per DIC treatment patterns in patients with sepsis-associated DIC following the onset of DICDIC: disseminated intravascular coagulationdate_rangeTime Frame:Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
- Incidence rates of clinical outcomes assessed in patients with sepsis-associated DICClinical outcomes are assessed at 14 days, 28 days, 60 days, 183 days, 365 days (1 year) and 730 days (2 years) of follow up. Clinical outcomes include thrombosis, major bleeding, organ failures, death, ICUs admission during the index hospitalization, discharge during the index hospitalization, length of index hospitalization. DIC: disseminated intravascular coagulationdate_rangeTime Frame:Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
- Cumulative incidences of clinical outcomes assessed in patients with sepsis-associated DICClinical outcomes are assessed at 14 days, 28 days, 60 days, 183 days, 365 days (1 year) and 730 days (2 years) of follow up. Clinical outcomes include thrombosis, major bleeding, organ failures, death, ICUs admission during the index hospitalization, discharge during the index hospitalization, length of index hospitalization. DIC: disseminated intravascular coagulationdate_rangeTime Frame:Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
- Number of participants per clinical characteristics in subgroup of patients who developed sepsis-associated DICDIC: disseminated intravascular coagulationdate_rangeTime Frame:Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
- Number of participants per treatment patterns in subgroup of patients who developed sepsis-associated DICDIC: disseminated intravascular coagulationdate_rangeTime Frame:Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
- Incidence rates of clinical outcomes in subgroup of patients who developed sepsis-associated DICClinical outcomes include thrombosis, major bleeding, organ failures, death, ICUs admission during the index hospitalization, discharge during the index hospitalization, length of index hospitalization.date_rangeTime Frame:Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
- Number of participants per clinical characteristics after the onset of DIC in patients with non-sepsis-associated DICDIC: disseminated intravascular coagulationdate_rangeTime Frame:Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
- Number of participants per treatment patterns after the onset of DIC in patients with non-sepsis-associated DICDIC: disseminated intravascular coagulationdate_rangeTime Frame:Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
- Incidence rates of clinical outcomes after the onset of DIC in patients with non-sepsis-associated DICClinical outcomes include thrombosis, major bleeding, organ failures, death, ICUs admission during the index hospitalization, discharge during the index hospitalization, length of index hospitalization.date_rangeTime Frame:Retrospective analysis of real world data between 01 JUN 2018 and 01 JUN 2023
Trial design
Trial Type info
ObservationalDescribes the nature of the clinical study.
Intervention Type info
OtherAn intervention is a drug, medical device, vaccine, or other treatment that is being studied in a trial or is already approved for all patients to use. An intervention can also include treatments like changing diet and exercise, or educating people about a health topic.
Trial Purpose info
OtherThe main reason the clinical trial is being done.
Allocation info
N/AAllocation is the way treatments are assigned to the people in the trial.
Blinding info
N/A“Blinding” means a person in a trial does not know what treatment they are using. Everyone in the trial knows which treatments they might get if they join the trial, but they do not always know which treatment they use during the trial.
Assignment info
N/AAn “assignment” is the way that people in a trial are assigned to use a treatment.
Trial Arms info
N/AA “trial arm” is a group of people in a trial. Each trial arm is assigned to use a specific treatment. Types of trial arms are: Experimental arm is a group assigned to use the treatment being studied in the trial Active comparator arm is a group assigned to use a treatment considered to be effective. The results of this group are compared to the results of the experimental arm. Placebo arm is a group assigned to use a placebo. A “placebo” looks like a treatment but usually does not have any real treatment. The results of this group are compared to the experimental arm. This helps make sure any effects that are seen in the experimental arm are actually caused by the main treatment being studied. No intervention arm is a group that is not assigned to use a treatment. The people in this group do not use any treatment during the trial.