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临床试验/NCT06877052
NCT06877052已完成不适用

Prediction of Venous Thrombosis After Fracture Operation: Comparative Analysis of Different Fracture Sites

Foshan Hospital of Traditional Chinese Medicine1 个研究点 分布在 1 个国家目标入组 429 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
429
试验地点
1
主要终点
WBC (White Blood Cell count)

研究概览

简要总结

The goal of this observational study is to analyze the clinical characteristics of patients who develop lower limb deep vein thrombosis (DVT) following fracture surgery, with a focus on comparing different fracture sites. The main question it aims to answer is: How do the clinical characteristics of postoperative DVT vary across different fracture sites? The study will involve 429 patients who have been diagnosed with postoperative lower limb DVT following fracture surgery. Data will be collected on patient demographics, fracture type, surgical approach, thrombus size, number, location, and the occurrence of complications such as pulmonary embolism (PE). Participants will also be evaluated for relevant laboratory markers and clinical factors, including coagulation parameters and inflammatory markers.

By examining how these factors differ across fracture sites and their relationship to thrombus characteristics, this study seeks to better understand the risk factors and clinical course of postoperative DVT in orthopedic patients. The findings will provide valuable insights for improving patient management strategies and reducing the risk of complications such as PE in those undergoing fracture surgery.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •(1) Age requirement: ≥18 years old, gender is not limited. (2) Including but not limited to rib fracture, femur fracture, tibia and fibula fracture, ankle fracture and other types of fracture (3) Patients with fractures who have undergone surgical treatment and patients with postoperative complications related to venous thrombosis.
  • •(3) The patient's clinical data (such as age, gender, fracture type, surgical method, postoperative recovery, etc.) and laboratory data (such as D-dimer, coagulation function, etc.) should be fully available.
  • •(4) Informed consent: Patients voluntarily participate in this study, sign informed consent, and promise to cooperate with the completion of the evaluation and follow-up in the study.
  • •(5) Patients with diabetes, hypertension and other comorbidities should be recorded, because these diseases may affect the occurrence of venous thrombosis.

排除标准

  • •(1) Patients with non-fracture types such as upper limb fracture and spinal fracture are not included.
  • •(2) Acute patients with symptoms of venous thrombosis such as deep vein thrombosis or pulmonary embolism, or patients with a history of significant thrombosis.
  • •(3) Patients whose clinical data or laboratory data are incomplete, resulting in no effective analysis.
  • •(4) Patients currently participating in other clinical trials or interventions. (5) Fracture patients who did not receive surgical treatment or only received conservative treatment.

结局指标

主要结局

WBC (White Blood Cell count)

时间窗: From January 2024 to December 2024

WBC (White Blood Cell count), measured in cells/µL,All these markers will be assessed at baseline (Day 0) and during monthly follow-up visits throughout the study period from January 2024 to December 2024. Data will be collected and summarized as.

PLT (Platelet count)

时间窗: From January 2024 to December 2024

PLT (Platelet count), measured in cells/µL; All these markers will be assessed at baseline (Day 0) and during monthly follow-up visits throughout the study period from January 2024 to December 2024. Data will be collected and summarized as.

ANC (Absolute Neutrophil Count)

时间窗: From January 2024 to December 2024

ANC (Absolute Neutrophil Count), measured in cells/µL; All these markers will be assessed at baseline (Day 0) and during monthly follow-up visits throughout the study period from January 2024 to December 2024. Data will be collected and summarized as.

Lymphocyte count

时间窗: From January 2024 to December 2024

Lymphocyte count, measured in cells/µL. All these markers will be assessed at baseline (Day 0) and during monthly follow-up visits throughout the study period from January 2024 to December 2024. Data will be collected and summarized as.

Activated Partial Thromboplastin Time (aPTT)

时间窗: From January 2024 to December 2024

Activated Partial Thromboplastin Time (aPTT), measured in seconds; All these markers will be assessed at baseline (Day 0) and during monthly follow-up visits throughout the study period from January 2024 to December 2024. Data will be collected and summarized as.

Fibrinogen

时间窗: From January 2024 to December 2024

Fibrinogen, measured in mg/dL; All these markers will be assessed at baseline (Day 0) and during monthly follow-up visits throughout the study period from January 2024 to December 2024. Data will be collected and summarized as.

Thrombin Time

时间窗: From January 2024 to December 2024

Thrombin Time, measured in seconds; All these markers will be assessed at baseline (Day 0) and during monthly follow-up visits throughout the study period from January 2024 to December 2024. Data will be collected and summarized as.

International Normalized Ratio (INR)

时间窗: From January 2024 to December 2024

International Normalized Ratio (INR), measured as a ratio,All these markers will be assessed at baseline (Day 0) and during monthly follow-up visits throughout the study period from January 2024 to December 2024. Data will be collected and summarized as.

次要结局

未报告次要终点

研究者

发起方
Foshan Hospital of Traditional Chinese Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Qilong Nie

DIRECTOR

Foshan Hospital of Traditional Chinese Medicine

研究点 (1)

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