SepsisNCT05998733
The Impact of Coagulation Disorders on the Diagnosis and Prognosis of Sepsis
An observational study of Sepsis and Coagulation Disorder, run by Ruijin Hospital at 1 site in China.
Trial summary
The study was a retrospective, single-center clinical study. From all patients admitted to the emergency ICU during the period of 2013.1.1-2019.12.31, the investigators screened all patients who met the criteria of 1) ≤7 days from symptom onset to enrollment; 2) patients who also met the criteria of the presence of… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Sepsis, Coagulation Disorder
- What is being tested?
- Early general coagulation function (5 items of coagulation) and thromboelastogram monitoring
- How many people
- 552 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 1 Jun 2024
- 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 90 years
- All sexes
- Adult, Older adult
Study population: The study was a retrospective, single-center clinical study. From all patients admitted to the emergency ICU during the period 2013.1.1-2019.12.31, all patients who met the enrollment criteria were screened, and the coagulation function indexes of patients with or without heparin or low molecular heparin before anticoagulation were retrospectively collected, the worst value of coagulation function of patients before heparin was recorded, and the organ function, inflammatory response, immune indexes, and the rate of conversion to severe disease of the patients were observed, so as to To investigate the role of conventional coagulation indices (FDP, D-dimer) and thromboelastography in the early diagnosis and prognosis of patients with sepsis.
Who may be able to join
- Time from clinical symptoms to admission ≤ 7 days；
- infection was diagnosed by clinician
- Systemic inflammatory response syndrome，Systemic inflammatory response syndrome was defined as the presence of 2 or more of the following: (1) temperature <36℃or >38℃, (2) heart rate >90 beats per minute, (3) respiratory rate >20 breaths per minute or PaCO2 < 32 mm Hg, or (4) white blood cell count ≥12 000 cells/mm3 or≤4000 cells/mm
Who cannot join
- Pregnancy and lactation
- Have hematological diseases (including acute and chronic leukemia, hemolytic anemia, hemophilia, aplastic anemia, bone marrow fibrosis, congenital or acquired coagulation factor deficiency, etc.)
- Anticoagulant or antiplatelet drug treatment
- 24 hours after severe trauma or surgery
- Autoimmune diseases
- cirrhosis
- Malignant tumor patients with personal history or undergoing radiotherapy, chemotherapy and targeted treatment
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Emergency, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Peili Chen, MD, +86 18502185109, elodiechen1986@163.com
Enqiang Mao, PhD, +86 13501747906, maoeq@yeah.net
About this study
Official title: Characteristics of Coagulation in Patients With Sepsis and the Role of Coagulation Disorders in the Development of Disease: a Retrospective Single-center Clinical Study
The study was a retrospective, single-center clinical study. From all patients admitted to the emergency ICU during the period of 2013.1.1-2019.12.31, the investigators screened all patients who met the criteria of 1) ≤7 days from symptom onset to enrollment; 2) patients who also met the criteria of the presence of clinical infections and Sequential Organ Failure Assessment (SOFA) score ≥2; and 3) met the exclusion criteria, and retrospectively collected coagulation indices of the patients before anticoagulation with or without the use of heparin or low molecular heparin, and recorded the worst values of coagulation function of patients before heparin were recorded, and the organ function, inflammatory response, immune indexes, and conversion rate of severe disease were observed, so as to investigate the role of conventional coagulation indexes (FDP, D-dimer) and thromboelastography in the early diagnosis of septicemia patients and to indicate the prognosis.
- Conditions
- Sepsis, Coagulation Disorder
- Being tested
- Early general coagulation function (5 items of coagulation) and thromboelastogram monitoring
- Keywords
- sepsis, coagulation disorders
- Medical subject headings
- Sepsis, Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early general coagulation function (5 items of coagulation) and thromboelastogram monitoringDiagnostic test
- Correlation analysis of sepsis severity with FDP and D-Dimer
- Discussion on the critical value and area under the curve of FDP and D-Dimer in diagnosis of sepsis
- Differences in age and sex of FDP and D-Dimer in diagnosis of sepsis
- Effect of FDP and D-Dimer diagnosis of sepsis on severe conversion rate and all-cause mortality of patients
- The difference of thromboelastogram in patients with sepsis of different severity
- Thromboelastogram items (R time α Correlation between angle, k time, maximum blood clot strength and comprehensive coagulation index) and sepsis
| Study group | Role | What they receive |
|---|---|---|
| sepsis group | diagnostic sepsis；age>18；Time from clinical symptoms to admission ≤ 7 days； It also meets the following two criteria: ① clinical infection② Sequential Organ Failure Assessment (SOFA) score ≥ 2 points at admission Receives: Diagnostic Test: Early general coagulation function (5 items of coagulation) and thromboelastogram monitoring | |
| non-sepsis group | diagnostic sepsis；age>18；Time from clinical symptoms to admission ≤ 7 days； It also meets the following two criteria: ① clinical infection②Systemic inflammatory response syndrome(SIRS)，SIRS was defined as the presence of 2 or more of the following: (1) temperature <36℃or >38℃, (2) heart rate >90 beats per minute, (3) respiratory rate >20 breaths per minute or PaCO2 < 32 mm Hg, or (4) white blood cell count ≥12 000 cells/mm3 or≤4000 cells/mm Receives: Diagnostic Test: Early general coagulation function (5 items of coagulation) and thromboelastogram monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
The plasma concentration of fibrin degradation products(FDP) in ug/ml
The plasma concentration of fibrin degradation products(FDP) was assessed after the participant was enrolled within 3 days of admission before the use of anticoagulant drugs
Measured: within 3 days of admission before the use of anticoagulant drugs
The plasma concentration of DDimer in ug/ml
The plasma concentration of DDimer was assessed after the participant was enrolled within 3 days of admission before the use of anticoagulant drugs
Measured: within 3 days of admission before the use of anticoagulant drugs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start1 Jun 2022
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Jun 2024 (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 Ruijin HospitalThe 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
- Retrospective
- Enrolment
- 552 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Enqiang Mao, PhD, Study chair, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05998733
- Sponsor's protocol ID
- 202300123
- Status last verified
- Jun 2023
- First submitted
- 24 Jul 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics of Coagulation in Patients With Sepsis and the Role of Coagulation Disorders in the Development of Disease: a Retrospective Single-center Clinical Study
- ClinicalTrials.gov ID
- NCT05998733
- Acronym / sponsor ID
- 202300123
- Conditions
- Sepsis, Coagulation Disorder
- Keywords
- sepsis, coagulation disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 552 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 21 Aug 2023 (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.
The study was a retrospective, single-center clinical study. From all patients admitted to the emergency ICU during the period of 2013.1.1-2019.12.31, the investigators screened all patients who met the criteria of 1) ≤7 days from symptom onset to enrollment; 2) patients who also met the criteria of the presence of clinical infections and Sequential Organ Failure Assessment (SOFA) score ≥2; and 3) met the exclusion criteria, and retrospectively collected coagulation indices of the patients before anticoagulation with or without the use of heparin or low molecular heparin, and recorded the worst values of coagulation function of patients before heparin were recorded, and the organ function, inflammatory response, immune indexes, and conversion rate of severe disease were observed, so as to investigate the role of conventional coagulation indexes (FDP, D-dimer) and thromboelastography in the early diagnosis of septicemia patients and to indicate the prognosis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sepsis group | – | Diagnostic Test: Early general coagulation function (5 items of coagulation) and thromboelastogram monitoringdiagnostic sepsis；age>18；Time from clinical symptoms to admission ≤ 7 days； It also meets the following two criteria: ① clinical infection② Sequential Organ Failure Assessment (SOFA) score ≥ 2 points at admission |
| non-sepsis group | – | Diagnostic Test: Early general coagulation function (5 items of coagulation) and thromboelastogram monitoringdiagnostic sepsis；age>18；Time from clinical symptoms to admission ≤ 7 days； It also meets the following two criteria: ① clinical infection②Systemic inflammatory response syndrome(SIRS)，SIRS was defined as the presence of 2 or more of the following: (1) temperature <36℃or >38℃, (2) heart rate >90 beats per minute, (3) respiratory rate >20 breaths per minute or PaCO2 < 32 mm Hg, or (4) white blood cell count ≥12 000 cells/mm3 or≤4000 cells/mm |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study was a retrospective, single-center clinical study. From all patients admitted to the emergency ICU during the period 2013.1.1-2019.12.31, all patients who met the enrollment criteria were screened, and the coagulation function indexes of patients with or without heparin or low molecular heparin before anticoagulation were retrospectively collected, the worst value of coagulation function of patients before heparin was recorded, and the organ function, inflammatory response, immune indexes, and the rate of conversion to severe disease of the patients were observed, so as to To investigate the role of conventional coagulation indices (FDP, D-dimer) and thromboelastography in the early diagnosis and prognosis of patients with sepsis.
Key inclusion criteria (3 listed)
- Time from clinical symptoms to admission ≤ 7 days；
- infection was diagnosed by clinician
- Systemic inflammatory response syndrome，Systemic inflammatory response syndrome was defined as the presence of 2 or more of the following: (1) temperature <36℃or >38℃, (2) heart rate >90 beats per minute, (3) respiratory rate >20 breaths per minute or PaCO2 < 32 mm Hg, or (4) white blood cell count ≥12 000 cells/mm3 or≤4000 cells/mm
Key exclusion criteria (7 listed)
- Pregnancy and lactation
- Have hematological diseases (including acute and chronic leukemia, hemolytic anemia, hemophilia, aplastic anemia, bone marrow fibrosis, congenital or acquired coagulation factor deficiency, etc.)
- Anticoagulant or antiplatelet drug treatment
- 24 hours after severe trauma or surgery
- Autoimmune diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early general coagulation function (5 items of coagulation) and thromboelastogram monitoring* Correlation analysis of sepsis severity with FDP and D-Dimer * Discussion on the critical value and area under the curve of FDP and D-Dimer in diagnosis of sepsis * Differences in age and sex of FDP and D-Dimer in diagnosis of sepsis * Effect of FDP and D-Dimer diagnosis of sepsis on severe conversion rate and all-cause mortality of patients * The difference of thromboelastogram in patients with sepsis of different severity * Thromboelastogram items (R time α Correlation between angle, k time, maximum blood clot strength and comprehensive coagulation index) and sepsis | Diagnostic test | non-sepsis group, sepsis group |
Primary outcome
The plasma concentration of fibrin degradation products(FDP) in ug/ml
Time frame: within 3 days of admission before the use of anticoagulant drugs
The plasma concentration of fibrin degradation products(FDP) was assessed after the participant was enrolled within 3 days of admission before the use of anticoagulant drugs
The plasma concentration of DDimer in ug/ml
Time frame: within 3 days of admission before the use of anticoagulant drugs
The plasma concentration of DDimer was assessed after the participant was enrolled within 3 days of admission before the use of anticoagulant drugs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Individual participant dataSharing planned: No
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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.
Enqiang Mao, PhD study chair
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Coagulation Disorder, run by Ruijin Hospital at 1 site in China.
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 3 inclusion and 7 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 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 peili CHEN, MD (+86 18502185109, elodiechen1986@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The plasma concentration of fibrin degradation products(FDP) in ug/ml (time frame: within 3 days of admission before the use of anticoagulant drugs). The study lists 2 primary outcomes in all. 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 21 Aug 2023.