Investigating how coagulation disorders affect sepsis diagnosis and prognosis
Characteristics of Coagulation in Patients With Sepsis and the Role of Coagulation Disorders in the Development of Disease: a Retrospective Single-center Clinical Study
This study looks at how blood clotting problems affect the diagnosis and outcomes of sepsis in patients admitted to the ICU with infections.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 552 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Ruijin Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT05998733 on ClinicalTrials.gov |
What this trial studies
This observational study retrospectively analyzes patients admitted to the emergency ICU over a six-year period to understand the impact of coagulation disorders on sepsis. It focuses on patients who developed clinical infections and had a Sequential Organ Failure Assessment (SOFA) score of 2 or higher. The study collects coagulation indices before anticoagulation treatment and monitors various health indicators to evaluate their role in diagnosing septicemia and predicting patient outcomes. The goal is to identify how conventional coagulation tests and thromboelastography can aid in early diagnosis and prognosis of sepsis.
Who should consider this trial
Good fit: Ideal candidates are patients admitted to the ICU with clinical infections and a SOFA score of 2 or higher within 7 days of symptom onset.
Not a fit: Patients with hematological diseases, those on anticoagulant therapy, or with severe trauma/surgery within the last 24 hours will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve early diagnosis and treatment strategies for patients with sepsis, potentially leading to better outcomes.
How similar studies have performed: While there is ongoing research in this area, the specific approach of correlating coagulation indices with sepsis prognosis in this manner is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Shanghai, Shanghai
- Department of Emergency, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Study coordinator: peili CHEN, MD
- Email: elodiechen1986@163.com
- Phone: +86 18502185109
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.