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Showing 1-11 of 11 trials
NCT07658885
This multicenter prospective observational study aims to develop and validate a deep learning-based artificial intelligence snake species identification system, and evaluate its clinical application efficacy in real-world emergency snakebite treatment scenarios. The primary research question it seeks to answer is: In real clinical settings in Zhejiang Province, can the artificial intelligence snake species identification system accurately identify common indigenous snake species causing bites, and improve the accuracy and diagnostic efficiency of snake species judgment for physicians at different levels of medical institutions? This study will be conducted simultaneously in 10 medical institutions in Zhejiang Province. investigators will prospectively enroll patients with snakebite who present to the hospital between June 2026 and December 2026 and can provide photographs of the offending snakes. The snake species identification results of both attending physicians and the artificial intelligence system will be recorded synchronously, and the patients' clinical treatment and prognosis data will be collected. All patients will be followed up until 30 days after discharge.
NCT03326492
There is little or no assessment under real-use conditions of the efficacy and the tolerance in the short, medium and long term of the antivenoms currently on the market and used in the treatment of snake bites. The main objective is to assess the short term tolerance (\< 2 hours post-injection) of the antivenom Inoserp Pan-Africa® (temporary market authorization) from Inosan laboratory currently available in Cameroon.
NCT07079137
India reports \~58,000 snakebite deaths/year, over 50% of global mortality. Clinical outcomes of antivenom may vary due to regional venom differences, delayed access to care, ineffective use of existing polyvalent antivenom. There is a need for an India-specific severity assessment tool because it improves risk stratification \& clinical decisions ,guides antivenom use, supports rural healthcare infrastructure, reduces morbidity, mortality, and financial burden. Existing scoring systems lack validation for Indian envenomation patterns. Variability in venom (both inter- and intra-species) leads to inconsistent clinical outcomes.Misapplication of non-Indian tools may cause: Inaccurate severity grading, inappropriate antivenom use, poor patient outcomes. PRIMARY OBJECTIVE: ● To determine the predictive accuracy of Snakebite Severity Score (SSS) done at the time of presentation in identifying syndrome specific core outcomes for snakebites. SECONDARY OBJECTIVES: * To evaluate the predictive accuracy of SSS in identifying patients at risk of mortality at 6 weeks * To determine the predictive accuracy of modified Snakebite Severity Score (mSSS) done at the time of presentation in identifying syndrome specific core outcomes for snakebites METHODOLOGY Study Duration: 18 months (Proposed) * Setting: Emergency Dept, Jubilee Mission Medical College * Sampling method :consecutive sampling * Sample Size Calculation: n = Z₍₁-α/₂)2 x SN (100-SN ) / l2 x P = 220 * Confidence Level: 95% (Z₍₁-α/₂₎ = 1.96) * Expected Sensitivity: 97% * Relative Allowable Error: 5% (l = 0.05) * Proportion: Based on core outcome occurrence = 0.22 * Drop-out Rate Assumed: 20% * minimum sample size = 264 Reference: Based on data from Dart et al."Validation of a Severity Score for the Assessment of Crotalid Snakebite,1999" INCLUSION AND EXCLUSION CRITERIA Inclusion Criteria: * All patients 'clinically suspected snakebite' * Presenting within 24 hours of the event * Age ≥18 years * Providing written informed consent Exclusion Criteria * Stings or bites other than snake * All patients who received antivenom or blood products at another institute * All patients with known hematological malignancies, coagulation disorders, chronic liver or renal failure * All patients known to be on warfarin, heparin or any newer oral or injectable anticoagulants * Individuals withdrawing a consent later on. STUDY FLOW AND DATA MANAGEMENT Study Flow: Enrollment \& Initial ED Assessment: History, examination, bite documentation, SSS scoring Baseline labs as per institutional protocol Monitoring \& Follow-Up Timepoints: T0: At presentation T+3h, +6h, +12h: Direct proforma, records review T+48h: Medical records Day 30 and Day 42 : Medical records \& telephonic follow-up Outcomes Monitored: Neurotoxicity, haemotoxicity , coagulopathy, local damage, AKI, hypotension No interference with clinical care or treatment decisions. DATA ANALYSIS PLAN: Software: SPSS v29 Continuous variables are measured by using Mean+/-SD or median IQR Categorical variables are reported as frequencies and percentages. ROC curve analysis for SSS and mSSS. Logistic regression for mortality. Subgroup and domain-wise analysis. ETHICAL CONSIDERATIONS: Ethics approval to be obtained. Informed consent will be ensured. Data anonymized and securely stored. No interference with patient treatment.
NCT02570347
Clinicians tend to overuse antibiotics in snake bite despite evidence from three previous clinical trials that failed to show a benefit. But, none of these trials was done in India. Further, the species of snake in two of these trials was quite different from that seen in the Indian setting limiting generalization of these findings. Hence, home-grown evidence is needed to persuade clinicians to use antibiotics rationally.
NCT04470791
The study aimed to determine the effect of local cryotherapy as a coadjuvant in patients with snakebite treated with F(ab')2 therapy venom at the Hospital Juárez de Mexico.
NCT03890016
20 minute Whole Blood Clotting Test(20'WBCT) recommended by World Health Organisation guidelines is probably the most routinely employed bed side screening tool in the country. The Modified Lee and White (MLW) method gives a value which when performed serially gives a trend in clotting time which the investigators hypothesise to be a better tool in serially assessing the victim compared to the 20'WBCT. The investigators propose that delayed reading of both MLW and 20'WBCT to check for clot stability at 30 minutes also provides added information in management of snake bite victims.
NCT01864200
This study will evaluate the recovery from copperhead snake bite in patients with mild or moderate venom effect. Potential subjects received CroFab antivenom or placebo. After blinded treatment and discharge, the subject returns to the clinic for follow-up assessments at day 3, 7, 14, and 28 after snake bite as well as follow-up telephone assessments on day 10, 17, and 24 after snake bite. The purpose of this study is to compare recovery in copperhead snake bite patients treated with antivenom vs placebo (no active drug) as measured by the Patient Specific Functional Scale (PSFS) at Day 14 follow-up. The primary efficacy endpoint of this study was achieved.
NCT02694952
Interventional, individually randomized, double (e.g. investigator and participant) blinded, parallel two-arm, non-inferiority trial to assess the efficacy of EchiTabPlus-ICP compared to FAV-Africa for the treatment of snakebite with envenoming.
NCT00639951
The purpose of this study is to compare whether a same total dose given up front as a single dose is more effective and as safe as the same dose given as a fractioned dose. Evaluate the Utility of the the Dry Tube Test Evaluating its Correlation with Coagulation Test Results (fibrinogen, platelets, INR, PT and PTT). Explore the Evolution of some Serum Markers (CK, DHL, metalloproteinase), Amount of Venom and Antivenom Levels and the Progression of Local Lesions.
NCT00636116
The purpose of this study is to establish if F(ab)2 antivenom (Anavip) is safe for crotalinae envenomation. Confirm its effectiveness in preventing the occurrence of delayed coagulopathies and compare the safety and efficacy with Fab antivenom (CroFab) in patients with Crotalinae envenomation.
NCT00811239
In northern Vietnam, a vast majority of the most severe envenomed patients are bitten by Bungarus multicinctus. Hitherto, these victims have received supportive care only. The aims of this study were to assess the possible efficacy and side effects of a newly produced antivenom.