NCT06891599招募中不适用
Advanced Coagulation Diagnostics Using ROTEM and Standard Coagulation Tests in Hospitalized Patients With Sepsis or Trauma - A Prospective Observational Study (ROSTIC - ROTEM for Sepsis and Trauma Induced Coagulopathy)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Detection of abnormal coagulation clusters via PCA of ROTEM in trauma and sepsis patients
研究概览
简要总结
This prospective observational study aims to investigate the ability of advanced ROTEM analysis using Principal Component Analysis (PCA) to detect early signs of disseminated intravascular coagulation (DIC) and trauma-induced coagulopathy (TIC) in hospitalized patients with sepsis or trauma. Standard coagulation tests and ROTEM measurements will be collected and analyzed in relation to clinical outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Trauma patients:
- •Trauma alarm activated at hospital admission New Injury Severity Score (NISS) > 15 Transfer to hospital within 7 days of trauma with NISS > 15
- •Sepsis patients:
- •Meeting Sepsis-3 criteria Receipt of intravenous beta-lactam or aminoglycoside antibiotics within 48 hours of admission
- •Control group:
- •Patients undergoing elective surgery without expected coagulopathy
排除标准
- •Trauma patients:
- •Isolated chronic subdural hematoma No underlying traumatic event despite trauma alarm Age <18 years
- •Sepsis patients:
- •Age <18 years
- •Control patients:
- •Ongoing anticoagulant treatment Life-threatening illness (ASA IV-V) Age <18 years
结局指标
主要结局
Detection of abnormal coagulation clusters via PCA of ROTEM in trauma and sepsis patients
时间窗: Through study completion, an average of 2 years
Detection of abnormal coagulation clusters via PCA of ROTEM in trauma and sepsis patients
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
终止
不适用
Effectiveness of ROTEM-based Coagulation Surveillance on Reducing Blood Product Utilization During Complex Spine SurgerySpine SurgeryRotational Thrombo-elastometry (ROTEM)NCT02758184Duke University21
尚未招募
不适用
Relationship of Point-of-care Coagulation Assays with Clinical Outcomes in Cardiac Surgery: a Retrospective Cohort StudyNCT06882759University Health Network, Toronto15,000
招募中
不适用
Coagulation analysis with ROTEM sigma versus ROTEM delta in liver transplantatioAll patients are eligible for liver transplantation, including whole organ transplantation, split liver transplantation and retransplantation.DRKS00034207niversitätsklinum Essen100
Unknown
不适用
A Gray Zone Approach of Rotational Thromboelastometry for Predicting Postoperative Bleeding in Cardiac Surgical PatientsOther Functional Disturbances Following Cardiac SurgeryPostoperative HemorrhageCoagulation Defect BleedingNCT01889732Samsung Medical Center200
已完成
不适用
Prediction of in-circuit coagulation using blood coagulation analyzer in continuous renal replacement therapycritically ill patientJPRN-UMIN000032224Department of Intensive Care Medicine, Sapporo Medical University School of Medicine60