Thrombelastography for Coagulopathy in Chinese Snakebites

Clinical Characteristics and Thromboelastographic Evaluation of Hematotoxic Snakebites in Southern China: A 9-year Retrospective Study

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.

Study Overview

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

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.

• Study Type: Observational
• Enrollment (Actual): 61

Contacts and Locations

Study Locations

• China
  • Zhanjiang, China
    • Central People's Hospital of Zhanjiang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
TEG group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	Up to 24 hours
Thromboelastography (TEG) K (Clot Formation Time) in Pit Viper Bite Patients	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.	Up to 24 hours
Thromboelastography (TEG) Alpha Angle in Pit Viper Bite Patients	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.	Up to 24 hours
Thromboelastography (TEG) Maximum Amplitude (MA) in Pit Viper Bite Patients	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.	Up to 24 hours
Thromboelastography (TEG) Ly30 in Pit Viper Bite Patients	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.	Up to 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality Rate	This outcome measure assesses the mortality rate in patients with pit viper envenomation and venom-induced consumptive coagulopathy. Mortality is defined as death within 30 days following the bite.	Up to 30 days
Duration of Hospital Stay	This outcome measure evaluates the number of days patients remain in the hospital after being bitten by a pit viper and receiving antivenom treatment. The duration of stay is measured from the time of admission to discharge.	From hospital admission to discharge
Incidence of Adverse Events	This outcome measure tracks the occurrence of any adverse events related to antivenom administration or the progression of coagulopathy. Adverse events are categorized by severity (mild, moderate, severe).	Up to 7 days

Collaborators and Investigators

• Sponsor: Hansung University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: February 18, 2025
• First Submitted That Met QC Criteria: March 2, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 2, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Coagulopathy; Snake Bite; Clotting Disorders; Toxicology; Pit Viper; TEG (Thromboelastography); Venom-induced Coagulopathy; Blood Coagulation Tests; Venomous Snake Bites
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Hematologic Diseases; Chemically-Induced Disorders; Hemorrhagic Disorders; Poisoning; Bites and Stings; Thrombophilia; Hemostatic Disorders; Blood Coagulation Disorders; Snake Bites; Disseminated Intravascular Coagulation
• Other Study ID Numbers: KY20250218

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No