Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:25 PM
Ignite Modification Date:
2025-12-24 @ 7:25 PM
NCT ID:
NCT06860503
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06860503
Study Brief:
Protocol Section:
NCT06860503