SepsisNCT04582188
The Early Coagulopathy for the Prognosis in Sepsis
An observational study of Sepsis and Coagulopathy, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
Trial summary
In this cohort study, the parameters (TM, TAT, PIC, tPAIC, et al.) associated with the hemostatic system will be collected in sepsis patients when admitted to the Intensive Critical Unit. Parameters will be evaluated for their prognostic function of 28 days mortality. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sepsis, Coagulopathy, Outcome, Fatal
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 5 Nov 2020to 31 Dec 2022
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All the patients diagnosed with sepsis in the ICU of Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
Who may be able to join
- Patients admitted to ICU of Union Hospital, Tongji Medical College, Huazhong University of Science and Technology from August 2020 to July 2022.
- Patients diagnosed with sepsis. The criteria for diagnosis is: 1. Infection or suspected infection; 2. SOFA score ≥ 2.
- Age interval: 18 years -- 80 years.
- Gender: unlimited.
- Signed informed consent form received.
- Results of the coagulation parameters tested within 24 hours after admission are available.
Who cannot join
- Pregnant and lactating women.
- With primary diseases that can cause thrombocytopenia or prolong prothrombin time, such as leukemia.
- Patients with severe liver dysfunction.
- Patients with anticoagulation or fibrinolysis medications within 72 hours before admission.
- Patients are in a procoagulation condition, such as VTE patients, protein C or protein S deficient individuals.
- Patients with chronic renal failure.
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- Patients need ECMO therapy.
- Patients with severe cardiopulmonary diseases or nervous system diseases.
- Patients at the end-stage of disease.
- Patients without signed informed consent forms.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: An Observational Study on the Prognostic Function of Early Coagulopathy in Sepsis Patients
In this cohort study, the parameters (TM, TAT, PIC, tPAIC, et al.) associated with the hemostatic system will be collected in sepsis patients when admitted to the Intensive Critical Unit. Parameters will be evaluated for their prognostic function of 28 days mortality.
Read the detailed description
The object of this study is to find the early mortality prognostic biomarkers within the hemostatic system in sepsis patients. Blood samples will be collected from sepsis patients at admission. Parameters reflect endothelial injury, such as thrombomodulin (TM), tissue type plasminogen activator inhibitor complex (tPAIC), parameters reflect procoagulation condition, such as thrombin-antithrombin complex (TAT), and parameters reflect hyperfibrinolysis, such as plasmin-plasmin inhibitor complex (PIC) will be tested. Based on the results of these parameters, sepsis patients will be divided into coagulation parameter normal or abnormal groups. Twenty-eight days of mortality will be determined by patient follow-up. Regression analysis will be used to evaluate the relationship between these parameters and the mortality of sepsis patients.
- Conditions
- Sepsis, Coagulopathy, Outcome, Fatal
- Keywords
- Sepsis, Thrombomodulin, Thrombin-antithrombin complexe, Plasmin-α2-plasmin inhibitor complex, Tissue plasminogen activator-plasminogen activator inhibitor-1 complex, Mortality
- Medical subject headings
- Sepsis, Hemostatic Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day all course mortality
Measured: 28 days from ICU-admission
Secondary outcomes (2)
Length of stay
Measured: 28 days from ICU-admission
Length of using vasopressor
Measured: 28 days from ICU-admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start5 Nov 2020 (estimated)
- Primary completion31 Mar 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 4 Weeks
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hua-Qing Shu, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04582188
- Sponsor's protocol ID
- UHICU20201001
- Status last verified
- Nov 2020
- First submitted
- 4 Oct 2020
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study on the Prognostic Function of Early Coagulopathy in Sepsis Patients
- ClinicalTrials.gov ID
- NCT04582188
- Acronym / sponsor ID
- UHICU20201001
- Conditions
- Sepsis, Coagulopathy, Outcome, Fatal
- Keywords
- Sepsis, Thrombomodulin, Thrombin-antithrombin complexe, Plasmin-α2-plasmin inhibitor complex, Tissue plasminogen activator-plasminogen activator inhibitor-1 complex, Mortality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 5 Nov 2020 (estimated)
- Primary completion
- 31 Mar 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 9 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this cohort study, the parameters (TM, TAT, PIC, tPAIC, et al.) associated with the hemostatic system will be collected in sepsis patients when admitted to the Intensive Critical Unit. Parameters will be evaluated for their prognostic function of 28 days mortality.
Detailed description
The object of this study is to find the early mortality prognostic biomarkers within the hemostatic system in sepsis patients. Blood samples will be collected from sepsis patients at admission. Parameters reflect endothelial injury, such as thrombomodulin (TM), tissue type plasminogen activator inhibitor complex (tPAIC), parameters reflect procoagulation condition, such as thrombin-antithrombin complex (TAT), and parameters reflect hyperfibrinolysis, such as plasmin-plasmin inhibitor complex (PIC) will be tested. Based on the results of these parameters, sepsis patients will be divided into coagulation parameter normal or abnormal groups. Twenty-eight days of mortality will be determined by patient follow-up. Regression analysis will be used to evaluate the relationship between these parameters and the mortality of sepsis patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All the patients diagnosed with sepsis in the ICU of Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
Key inclusion criteria (6 listed)
- Patients admitted to ICU of Union Hospital, Tongji Medical College, Huazhong University of Science and Technology from August 2020 to July 2022.
- Patients diagnosed with sepsis. The criteria for diagnosis is: 1. Infection or suspected infection; 2. SOFA score ≥ 2.
- Age interval: 18 years -- 80 years.
- Gender: unlimited.
- Signed informed consent form received.
Key exclusion criteria (10 listed)
- Pregnant and lactating women.
- With primary diseases that can cause thrombocytopenia or prolong prothrombin time, such as leukemia.
- Patients with severe liver dysfunction.
- Patients with anticoagulation or fibrinolysis medications within 72 hours before admission.
- Patients are in a procoagulation condition, such as VTE patients, protein C or protein S deficient individuals.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
28-day all course mortality
Time frame: 28 days from ICU-admission
2 secondary outcomes
Length of stay
Time frame: 28 days from ICU-admission
Length of using vasopressor
Time frame: 28 days from ICU-admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
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Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Coagulopathy, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huaqing Shu, Dr. (13437284416, 370247973@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day all course mortality (time frame: 28 days from ICU-admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2020.