Clinical Characteristics and Thromboelastographic Evaluation of Hematotoxic Snakebites in Southern China: A 9-year Retrospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Thromboelastography (TEG) R (Reaction Time) in Pit Viper Bite Patients Thromboelastography (TEG) R (Reaction Time) in Pit Viper Bite Patients Thromboelastography (TEG) R (Reaction Time) in Pit Viper Bite Patients
研究概览
简要总结
This study aims to evaluate the coagulation disorders caused by pit viper bites in patients from Zhanjiang and surrounding areas. The investigators will assess the effectiveness of thromboelastography (TEG) in evaluating coagulation function in these patients. The study will compare TEG results with conventional coagulation tests (CCTs) to understand its potential clinical value in diagnosing and managing coagulopathy caused by venomous snake bites.
详细描述
Pit viper bites are a significant cause of envenomation in Guangzhou and surrounding regions, leading to severe coagulation disorders. Early and accurate assessment of coagulation function is critical for effective management and treatment. Traditional coagulation tests, such as prothrombin time (PT) and activated partial thromboplastin time (APTT), are commonly used but may not fully reflect the complex coagulopathy induced by venom.
This observational study will include patients who have been bitten by pit vipers in Guangzhou and surrounding areas. The aim is to evaluate the role of thromboelastography (TEG) in the diagnosis and management of coagulopathy in these patients. The investigators will compare TEG results with conventional coagulation tests (CCTs) to assess their agreement and the additional insights TEG may provide in identifying coagulation abnormalities.
The study will observe participants from the moment of admission and monitor their coagulation function through TEG and CCTs. Data will be collected on clinical outcomes, including any signs of disseminated intravascular coagulation (DIC), thromboembolic events, or bleeding complications. The investigators aim to identify the clinical value of TEG in managing coagulopathy in pit viper bite cases and to explore whether TEG can be used as a more reliable and timely diagnostic tool.
This study will help improve the understanding of coagulopathy induced by pit viper venom and may potentially guide the development of better diagnostic and treatment protocols for venomous snake bites.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: Participants aged 18-65 years.
- •Diagnosis: Confirmed diagnosis of venom-induced consumptive coagulopathy caused by snake envenomation.
- •Time of Enrollment: Participants who present with symptoms of venom poisoning within 6 hours of snake bite.
- •Consent: Capable of providing written informed consent, or consent provided by a legal guardian if the participant is incapacitated.
- •Vital Signs: Stable vital signs at the time of enrollment, with systolic blood pressure > 90 mmHg.
- •Laboratory Results: Coagulation parameters (e.g., PT, aPTT, fibrinogen, platelet count) indicating acute coagulopathy.
排除标准
- •Pregnancy or Breastfeeding: Women who are pregnant or breastfeeding.
- •Severe Comorbidities: Participants with severe liver disease (e.g., cirrhosis), renal failure, or significant cardiovascular conditions (e.g., heart failure).
- •Previous Snake Envenomation: Participants who have received antivenom for a snake bite in the past 30 days.
- •Severe Allergies: Known allergy to snake venom antivenom or any of its components.
- •Concurrent Participation in Other Clinical Trials: Participants who are currently enrolled in another clinical trial.
- •Severe Coagulopathy or Bleeding Disorders: Participants with known pre-existing coagulation disorders such as hemophilia, or those with abnormal baseline blood tests suggesting coagulopathy unrelated to the snake bite.
- •Immunocompromised Patients: Individuals with HIV/AIDS, or who are on immunosuppressive therapy.
结局指标
主要结局
Thromboelastography (TEG) R (Reaction Time) in Pit Viper Bite Patients Thromboelastography (TEG) R (Reaction Time) in Pit Viper Bite Patients Thromboelastography (TEG) R (Reaction Time) in Pit Viper Bite Patients
时间窗: Up to 24 hours
This outcome measures the Reaction Time ® as part of the TEG assessment. R reflects the time to the initial clot formation and provides insight into the patient's ability to form a clot after a venomous pit viper bite. A prolonged R value may indicate a coagulation disorder.
Thromboelastography (TEG) K (Clot Formation Time) in Pit Viper Bite Patients
时间窗: Up to 24 hours
This outcome measures the Clot Formation Time (K) as part of the TEG analysis. K indicates the time it takes for the clot to form after the initial reaction, helping assess the speed of clot progression and the strength of coagulation. Prolonged K values may suggest fibrinogen deficiency or clotting factor depletion due to venom.
Thromboelastography (TEG) Alpha Angle in Pit Viper Bite Patients
时间窗: Up to 24 hours
This outcome measures the Alpha Angle, which reflects the rate of clot formation. A reduced Alpha Angle may indicate poor fibrinogen function or depletion, a key indicator of venom-induced coagulopathy.
Thromboelastography (TEG) Maximum Amplitude (MA) in Pit Viper Bite Patients
时间窗: Up to 24 hours
This outcome measures the Maximum Amplitude (MA), which assesses the strength of the clot. Decreased MA values could indicate weakened clot strength, a potential sign of venom-induced consumption coagulopathy. This helps identify patients at high risk of hemorrhagic complications.
Thromboelastography (TEG) Ly30 in Pit Viper Bite Patients
时间窗: Up to 24 hours
This outcome measures the Ly30, which represents the percentage of clot lysis 30 minutes after reaching maximum amplitude. Increased Ly30 values may indicate excessive fibrinolysis, which is common in patients with severe venom-induced coagulopathy.
次要结局
- Mortality Rate(Up to 30 days)
- Duration of Hospital Stay(From hospital admission to discharge)
- Incidence of Adverse Events(Up to 7 days)