Pit Viper BiteNCT06860503
Thrombelastography for Coagulopathy in Chinese Snakebites
An observational study of Pit Viper Bite and Coagulopathy, run by Hansung University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pit Viper Bite, Coagulopathy, Thromboelastography (TEG)
- How many people
- 61 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2015to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pit Viper Bite, Coagulopathy, Thromboelastography (TEG), Venom-induced Consumptive Coagulopathy, Coagulation Disorder, Snake Envenomation
- Keywords
- Pit Viper, TEG (Thromboelastography), Coagulopathy, Snake Bite, Venom-induced Coagulopathy, Clotting Disorders, Blood Coagulation Tests, Toxicology, Venomous Snake Bites
- Medical subject headings
- Hemostatic Disorders, Snake Bites, Disseminated Intravascular Coagulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 24 hours
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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).
Measured: Up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start1 Jan 2015
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pit Viper BiteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hansung University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06860503
- Sponsor's protocol ID
- KY20250218
- Status last verified
- Mar 2025
- First submitted
- 18 Feb 2025
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristics and Thromboelastographic Evaluation of Hematotoxic Snakebites in Southern China: A 9-year Retrospective Study
- ClinicalTrials.gov ID
- NCT06860503
- Acronym / sponsor ID
- KY20250218
- Conditions
- Pit Viper Bite, Coagulopathy, Thromboelastography (TEG), Venom-induced Consumptive Coagulopathy, Coagulation Disorder, Snake Envenomation
- Keywords
- Pit Viper, TEG (Thromboelastography), Coagulopathy, Snake Bite, Venom-induced Coagulopathy, Clotting Disorders, Blood Coagulation Tests, Toxicology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Hansung UniversityUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 6 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
3 secondary outcomes
Mortality Rate
Time frame: Up to 30 days
Duration of Hospital Stay
Time frame: From hospital admission to discharge
Incidence of Adverse Events
Time frame: Up to 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pit Viper Bite and Coagulopathy, run by Hansung University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Up to 24 hours). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.