Clinical trial NCT06860503: Thrombelastography for Coagulopathy in Chinese Snakebites
Official title: Clinical Characteristics and Thromboelastographic Evaluation of Hematotoxic Snakebites in Southern China: A 9-year Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pit Viper Bite
Coagulopathy
Thromboelastography (TEG)
Venom-induced Consumptive Coagulopathy
Coagulation Disorder
Snake Envenomation
Disseminated Intravascular Coagulation (DIC)
Keywords: Pit Viper
TEG (Thromboelastography)
Coagulopathy
Snake Bite
Venom-induced Coagulopathy
Clotting Disorders
Blood Coagulation Tests
Toxicology
Venomous Snake Bites
Lead sponsor: Hansung University
Sponsor class: OTHER
First posted: 2025-03-06
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study will include adult patients aged 18 to 65 years diagnosed with venom-induced consumptive coagulopathy (VICC) following a pit viper snake bite. Participants must show clinical signs of envenomation (e.g., swelling, pain, coagulopathy such as prolonged PT, aPTT, low fibrinogen, and platelet count), confirmed by laboratory tests.

Eligible patients will present to a medical facility within 6 hours of the bite and require antivenom treatment. Both male and female patients of all ethnicities will be included to reflect the general population affected by pit viper envenomation.

Exclusion criteria include pregnancy, severe comorbidities, or known allergies to antivenom. Approximately 50 to 100 patients will be recruited to evaluate the clinical outcomes after antivenom treatment for VICC.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Up to 24 hours
measure: Thromboelastography (TEG) K (Clot Formation Time) in Pit Viper Bite Patients
timeFrame: Up to 24 hours
measure: Thromboelastography (TEG) Alpha Angle in Pit Viper Bite Patients
timeFrame: Up to 24 hours
measure: Thromboelastography (TEG) Maximum Amplitude (MA) in Pit Viper Bite Patients
timeFrame: Up to 24 hours
measure: Thromboelastography (TEG) Ly30 in Pit Viper Bite Patients
timeFrame: Up to 24 hours
Secondary outcomes:
measure: Mortality Rate
timeFrame: Up to 30 days
measure: Duration of Hospital Stay
timeFrame: From hospital admission to discharge
measure: Incidence of Adverse Events
timeFrame: Up to 7 days
Other outcomes:
Locations:
city: Zhanjiang
country: China
facility: Central People's Hospital of Zhanjiang
Study officials:
References: