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Snake Bites clinical trials

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NCT ID: NCT06304714 Not yet recruiting - Hemorrhage Clinical Trials

Effects of Bothrops Spp. Snake Envenomation on Willebrand Factor Activity in Martinique and French Guiana

WBOTHROPS
Start date: April 1, 2024
Phase:
Study type: Observational

In 2017, the World Health Organization placed snakebites at the top of its list of neglected tropical diseases in an effort to facilitate funding for prevention programs, improve access to anti-venom, and stimulate new research in this area. Between 5 and 25 cases per 100 000 inhabitants are reported per year in French Guiana and Martinique. Before the era of anti-venom immunotherapy, envenomations by Bothrops snake bites in French Guiana and Martinique could quickly become life-threatening with a mortality rate close to 30%. Today, the administration of fragments of Fab or (Fab')2 immunoglobulins gives anti-venoms an excellent capacity to neutralise venom toxins, which has reduced mortality to less than 1% in the case of early hospital treatment In French Guiana, envenomation by Bothrops bites is characterized by local signs such as intense pain, rapidly expanding oedema, haemorrhagic phlyctenes and sometimes muscle necrosis. The local inflammatory and haemorrhagic damage is related to the enzymatic activities of the toxins contained in the venom (metallo-proteinases, disintegrins, and phospholipases A2, in particular). At the systemic level, venom serine proteases and metalloproteinases activate the coagulation cascade by multiple mechanisms (activation of coagulation factors X and V and of protrombin, thrombin-like and fibrinogenolytic enzymatic properties) and are responsible for the collapse of coagulation factors making the blood incoagulable. The metalloproteinases "hemorrhagins" destroy the vessel wall and are the cause of locoregional and systemic hemorrhage. Envenomations by bites of Bothrops lanceolatus in Martinique have particular characteristics. Despite the genetic similarity with their congeners in French Guiana, envenomation by bites of Bothrops lanceolatus is characterized by the development of very intense local inflammatory signs (little haemorrhage) and the occurrence of thrombotic complications such as cerebral, pulmonary or myocardial infarction. The mechanisms behind this thrombotic presentation are not known. The large amount of metalloproteinases in the composition of Bothrops lanceolatus venom is believed to be responsible for destruction of vascular endothelium and pro-thrombotic state. Bothrops lanceolatus bite envenomations have been reported to be frequently complicated by generalized infections, disseminated intravascular coagulation and the occurrence of multi-visceral failure syndrome. This observation suggests abnormalities in endothelial function in which changes in Willebrand factor expression have been implicated. The investigators hypothesize that plasma Willebrand factor (VW) activity and the intensity of endothelial activation are different depending on the Bothrops snake species involved in the bites in Guyana and Martinique. Due to the specific properties of the venoms of each Bothrops species, the activity of the Willebrand factor (VW) and the consequences in terms of endothelial activation would be different and responsible for the clinico-biological characteristics according to the geographical origin of the snakes. The investigators will demonstrate that the accumulation of Willebrand factor (VW) and the increase in its activity are responsible for the endothelial activation and micro-thrombosis observed during envenomations by Bothrops lanceolatus bites, whereas the decrease in its activity induced by the venoms of endemic Bothrops from Guyana is responsible for haemorrhagic phenomena. This study will highlight the importance of changes in Willebrand factor activity on endothelial activation and the initiation of micro-thrombosis in the case of Bothrops lanceolatus envenomations and on primary haemostasis and bleeding disorders in the case of endemic Bothrops in Guyana. This new knowledge is important insofar as individualised therapeutic management can be proposed. Indeed, several studies have shown that adjuvant treatment of thrombotic microangiopathies, such as thrombotic thrombocytopenic purpura, with blood products (fresh frozen plasma) or plasma exchange, improves endothelial dysfunction and the prognosis of patients.

NCT ID: NCT06124872 Enrolling by invitation - Epidemiology Clinical Trials

Mapping Snakebite Risk in Kenya and Eswatini

Start date: June 1, 2023
Phase:
Study type: Observational

The goal of this observational study is to learn about how snakebite risk varies in different environments in Kenya and understand how this information can be used to support decision makers. The main questions it aims to answer are: 1. To what extent can information on snakebite cases and data on geographic, climatic and sociodemographic factors be used to predict geographical variation in snakebite risk in Kenya and Eswatini? 2. What is the most effective means of presenting outputs from spatial analysis of snakebite risk to ensure its effective use in research and healthcare decision making? Participants in the community survey will be asked survey questions about the history of snakebite in their household. Participants in the key informant interviews will be interviewed to understand how data on snakebite risk can be best presented to support their work.

NCT ID: NCT05954806 Completed - Clinical trials for Envenomation, Snakebite

Clinical Profile and Antivenom Use in Hump-nosed Pit Viper Bites in Kerala, South India: A Review.

Start date: March 12, 2022
Phase:
Study type: Observational

Several controversies exist in Hypnale bite management in Kerala. Even though leading bodies like WHO recommend against using antivenom for hypnale bites, many physicians still administer antivenom for snakebites even when the culprit snake is identified. Anecdotal experience suggests that the reasons for doing so range from lack of confidence in the identification of the snake, confusion as to whether or not to approach it syndromically and symptomatically rather than relying on the species identification, doubts as to whether there exists para-specific neutralization capability for the available polyvalent antivenom and fear of medicolegal culpability in denying antivenom in a case of 'snake envenomation'. To date, these domains and rationale have not been studied. It is also to be kept in mind that the evidence behind the WHO recommendation against the use of antivenom in Hypnale is based on expert opinion and case reports. The investigators intend to compare clinical manifestation and outcome amongst Hypnale hypnale bite patients who received the polyvalent antivenom to those who did not. The investigators also intend to describe the clinical and laboratorical profile of patients with Hypnale hypnale envenomation .

NCT ID: NCT05872373 Enrolling by invitation - Snakebite Clinical Trials

Snakebite Prevention and First Aid Through Community Engagement

SPACE
Start date: September 1, 2022
Phase: N/A
Study type: Interventional

This study will be a community trial conducted in two Upazila (sub-district) of Bangladesh- Kalapara, Patuakhali district and Shibganj, Chapainawabganj district. Kalapara upazila will be the intervention area and Shibganj will be the control area. From both the control and intervention areas, 30 community clinics will be randomly selected. Each community clinic serves 6,000 people and consists of 3 'wards'. So, the sample size will be 1,80,000 in the control and intervention areas, respectively. We would first perform formative research and survey to comprehend the burden and the community's perception of managing and preventing snakebite incidents. Data gathered through this assessment will contribute to finalizing our study interventions. The major goals of these interventions are to enhance community involvement and first aid awareness. Community participation will be addressed through 'Uthan Boithok' (courtyard meeting), health education sessions in schools, community clinics, and Upazila Health Complex (UHC) by displaying/using IEC (Information, Education, and Communication) materials (posters, flip charts, leaflets etc.), traditional songs on snakebite prevention and first aid management. Other interventions will include short audiovisual clips and community radio broadcasts, the development of Snakebite Support Groups (SBSG), and speedy referral responses. These interventions will be evaluated through a baseline survey, a midline process evaluation, and an end-line survey. The final assessment process will be completed by comparing the findings of the baseline and end-line surveys as well as by using the hospital surveillance system. Estimated cases per year and the number of patients who attended the hospital for treatment will be the main assessment criteria. In this trial, the primary outcome, the incidence of snakebite cases, will be modelled using a mixed effects Poisson regression model to obtain incidence rate ratios (IRRs) comparing the intervention to the control group. Therefore, this proposed project's community participation and health system-building initiatives will also help to build community awareness and quick treatment response in rural communities which in the long run will reduce the morbidity and mortality from snakebite incidence in Bangladesh.

NCT ID: NCT05717062 Recruiting - Snakebite Clinical Trials

Broad-spectrum Rapid Antidote: Varespladib IV to Oral Trial for Snakebite (BRAVIO)

BRAVIO
Start date: May 30, 2023
Phase: Phase 2
Study type: Interventional

This is a multicenter,randomized,double-blind, placebo-controlled, phase 2 study designed to evaluate the safety, tolerability and efficacy of a continuous rate infusion (CRI) of IV varespladib followed by transition to the oral dosage form, varespladib-methyl, concurrently with SOC, in participants bitten by venomous snakes. Note: Funding Source - FDA-OOPD

NCT ID: NCT04996264 Completed - Envenoming, Snake Clinical Trials

Broad-spectrum Rapid Antidote: Varespladib Oral for Snakebite

BRAVO
Start date: August 15, 2021
Phase: Phase 2
Study type: Interventional

This is a multicenter, randomized, double-blind, placebo-controlled, phase 2 study designed to evaluate the safety, tolerability and efficacy of varespladib-methyl, concurrently with standard of care (SOC), in subjects bitten by venomous snakes.

NCT ID: NCT04845022 Recruiting - Clinical trials for THROMBOTIC MICROANGIOPATHY

Incidence of Snakebite Associated Thrombotic Microangiopathy & Role of Peripheral Blood Smear as a Predictor of Clinical Outcome

Start date: January 28, 2021
Phase:
Study type: Observational

The aim of this study is to find the overall incidence of thrombotic microangiopathy in snakebite victims. As we know snakebite is a common in tropical regions. Many a times the early diagnosis of TMA is missed and precious time which could have helped in improving the patient prognosis is lost. Also via this study we wish to learn the role of cost effective test like peripheral smear which could help learn morphological picture of red blood cells and thus help in early prediction of patients clinical prognosis.

NCT ID: NCT04733781 Not yet recruiting - Clinical trials for Musculoskeletal Pain

Subcutaneous Injection of Large Volumes of Tumescent Lidocaine and Epinephrine by Laypersons

TLE-RCT
Start date: February 22, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

This research is intended to show that it is safe and not difficult for nearly anyone to inject at least 125ml of a dilute solution of tumescent lidocaine and epinephrine (TLE), where a TLE solution consists of lidocaine (1gm/L) and epinephrine (1mg/L) in normal saline.

NCT ID: NCT04520282 Completed - Snake Bites Clinical Trials

Hemostatic Variables In Snakebite Study

HISS
Start date: March 15, 2022
Phase:
Study type: Observational

Background Novelty The global assays of coagulation, namely the viscoelastometric tests and clot waveform has never been studied in detail before in snakebite victims. The pathophysiology of VICC including specific factor deficiencies and serial trend in blood cell indices amongst various hematotoxic snakebite in the region is not known. No Indian study to date has systematically examined the changes in early laboratory tests results in envenomed and non envenomed snakebite victims.

NCT ID: NCT04470791 Completed - Snake Bites Clinical Trials

Cryotherapy as a Coadjuvant in Crotaline Snakebite Management With Antivenom.

Start date: January 1, 2015
Phase: N/A
Study type: Interventional

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.