Thrombelastography for Coagulopathy in Chinese Snakebites

NCT06860503 | Completed

• 1 other identifier: KY20250218
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Mortality Rate

  Up to 30 days

• Duration of Hospital Stay

  From hospital admission to discharge

• Incidence of Adverse Events

  Up to 7 days

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hansung University: lead

Study Sites (1)

Central People's Hospital of Zhanjiang

Zhanjiang, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples will be collected from participants who have suffered pit viper bites. These samples will be used to perform coagulation tests, including thromboelastography (TEG) and traditional clotting tests (CCTs). The samples will be analyzed to assess coagulation disorders and the effectiveness of various diagnostic techniques. No DNA will be extracted or analyzed from these samples.

MeSH Terms

Conditions

Hemostatic Disorders; Snake Bites; Disseminated Intravascular Coagulation

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Bites and Stings; Poisoning; Chemically-Induced Disorders; Wounds and Injuries; Blood Coagulation Disorders; Thrombophilia

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: March 6, 2025
• Study Start: January 1, 2015
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 6, 2025

Record last verified: 2025-03

Locations

CN (1)