Thrombelastography for Coagulopathy in Chinese Snakebites

Hansung University

Status: Completed

Conditions: Disseminated Intravascular Coagulation (DIC); Coagulopathy; Venom-induced Consumptive Coagulopathy; Coagulation Disorder; Pit Viper Bite; Thromboelastography (TEG); Snake Envenomation

Study type: Observational

Funder types: Other

Identifiers

NCT06860503

KY20250218

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 61 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

61 participants in 2 patient groups

TEG group

Description:

Participants in this group are patients diagnosed with pit viper envenomation. They will undergo thromboelastography (TEG) testing to assess coagulation function. TEG testing will be performed at the time of hospital admission, as well as periodically during their treatment process, based on the clinical needs of each patient. The primary focus is on identifying coagulation abnormalities and monitoring changes over time.

CCT group

Description:

Participants in this cohort are also diagnosed with pit viper envenomation, and they will undergo conventional coagulation tests (CCTs) such as PT, APTT, and fibrinogen levels. These tests will be used to monitor coagulation disorders and guide clinical management. The group will be compared to the TEG group to evaluate the effectiveness and accuracy of TEG in diagnosing venom-induced coagulopathy.