The Impact of Coagulation Disorders on the Diagnosis and Prognosis of Sepsis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

552 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-01

Study Completion Date

2024-06-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Sepsis Coagulation Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

Early general coagulation function (5 items of coagulation) and thromboelastogram monitoring

Intervention Type DIAGNOSTIC_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

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

Early general coagulation function (5 items of coagulation) and thromboelastogram monitoring

Intervention Type DIAGNOSTIC_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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No