- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06703645
Evaluation of Snakebite Cases in Assiut Governorate, Egypt (Prospective Study)
- Study the sociodemographic profile of snakebite victims in Assiut Governorate.
- Portray the clinical profile of snakebite victims admitted to Assiut University , El Eman General Hospital and Assiut General Hospital.
- Assess the predictors of severity and outcome of cases.
Study Overview
Status
Detailed Description
Snake's envenomation is a serious socio-medical problem, which causes considerable mortality and morbidity, with approximately 125,000 deaths worldwide annually. There were 4.5 to 5.4 million bites every year, and of those figures, 40-50% had some clinical disability as a result. Furthermore, the death from such an issue could go somewhere between 80,000 and 130,000 individuals each year. In the Middle East and North Africa, there are over 70,000 snakebites bites each year.
There are many species of snakes, approximately 3,700 species of snakes worldwide only about 15% are venomous belong to the four large families including Viperidae, Colubridae, Elapidae and Atractaspidinae. Two of these toxic species are widespread in Egypt; the family Viperidae and the family Elapidae Egyptian copra Naja Haje.
Snake venoms are complex mixtures consisting of enzymatic components e.g., proteolytic enzymes e.g., serine protease and metalloproteases (SVMPs), non-enzymatic components e.g., cysteine-rich secretory proteins (CRISP), amines, lipids, nucleotides, and carbohydrates. Venoms also contain inorganic cations that are presumed to function as cofactors and include sodium, calcium, potassium, magnesium, and zinc.
Snake venoms are usually classified as hemotoxic or neurotoxic. Snakes of the Viperidae family have venom containing proteins that can disrupt the coagulation cascade, the hemostatic system and tissue integrity. In contrast, neurotoxic venoms, which are typical of the Elapidae snakes, contain several toxins that primarily affect the peripheral nervous system, in particular the neuromuscular junction.
Depending on the species of snakes, manifestations can be localized symptoms of mild pain, progressive edema, ecchymosis, and tissue necrosis and generalized ones as spontaneous bleeding e.g., bleeding per gums, epistaxis, hematuria, vaginal bleeding, hematemesis, hematochezia, hemoptysis, hemolytic anemia and hemolytic jaundice with hemototoxic snake venom. In severe cases patients may develop acute renal, myocardial infarction, disseminated intravascular coagulation, or even death. Ptosis, diplopia, dysphagia, trunk and limbs weakness, and respiratory paralysis which can lead to respiratory failure and apnea with neurotoxic snake venom.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Rania Alkady Mohamed, demonstrator
- Phone Number: 01153387577
- Email: raniaalkady4@gmail.com
Study Contact Backup
- Name: Hala Mohammed Fathy, Professor
- Phone Number: +20 1098038310
- Email: halamfk2015@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Cases will be collected from emergency departments, inpatient units of Assiut University Hospitals, El Eman General Hospital and Assiut General Hospital. All cases will be evaluated by detailed history, examination, investigations and through sheet which consist of:
- Detailed information regarding demographic and epidemiological parameters such as age, sex, residence, occupation, site, time and place of bite in addition to type of snake if identification was obtained.
Clinical manifestations:
- Local manifestations
Systemic manifestations
- Hematological e.g., spontaneous bleeding like epistaxis, hematemesis, melena, and hematuria.
- Neurological e.g., ptosis, dysphonia, dysphagia, and descending paralysis.
- Cardiovascular e.g., dizziness, palpitation, faintness, hypotension, cardiac arrhythmias, and shock.
- Respiratory e.g., tachypnea and shortness of breathing
- The severity of envenomation will be assessed using the scoring and grading systems
Description
Inclusion Criteria:
- Patients admitted with a reliable history of snakebite.
- Presence of fang marks and/or signs of local and systemic envenomation.
Exclusion Criteria:
- Fake or uncertain snakebites.
- Patients with history of hematological disorders, liver diseases, renal diseases and anticoagulation therapy in the past week.
- Patients who are not willing to participate in the study.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants with recovery
Time Frame: through study completion, an average of 1 year".
|
|
through study completion, an average of 1 year".
|
|
Number of Participants with Death
Time Frame: through study completion, an average of 1 year".
|
Any complication due to snake bite end with death as respiratory arrest, disseminated intravascular coagulation and renal failure.
|
through study completion, an average of 1 year".
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Hala Mohammed Fathy, Professor, Assiut University
- Study Director: Nora Zeidan Abdellah, Assistant lecture, Assiut University
Publications and helpful links
General Publications
- Padhiyar R, Chavan S, Dhampalwar S, Trivedi T, Moulick N. Snake Bite Envenomation in a Tertiary Care Centre. J Assoc Physicians India. 2018 Mar;66(3):55-9.
- Namal Rathnayaka R, Ranathunga PAN, Kularatne SA. Thrombotic Microangiopathy, Hemolytic Uremic Syndrome, and Thrombotic Thrombocytopenic Purpura Following Hump-nosed Pit Viper (Genus: Hypnale) Envenoming in Sri Lanka. Wilderness Environ Med. 2019 Mar;30(1):66-78. doi: 10.1016/j.wem.2018.10.003. Epub 2019 Jan 31.
- Langley R, Haskell MG, Hareza D, King K. Fatal and Nonfatal Snakebite Injuries Reported in the United States. South Med J. 2020 Oct;113(10):514-519. doi: 10.14423/SMJ.0000000000001156.
- Kumar KS, Narayanan S, Udayabhaskaran V, Thulaseedharan NK. Clinical and epidemiologic profile and predictors of outcome of poisonous snake bites - an analysis of 1,500 cases from a tertiary care center in Malabar, North Kerala, India. Int J Gen Med. 2018 Jun 5;11:209-216. doi: 10.2147/IJGM.S136153. eCollection 2018.
- Kang S, Moon J, Chun B. Does the traditional snakebite severity score correctly classify envenomated patients? Clin Exp Emerg Med. 2016 Mar 31;3(1):34-40. doi: 10.15441/ceem.16.123. eCollection 2016 Mar.
- Jenkins TP, Ahmadi S, Bittenbinder MA, Stewart TK, Akgun DE, Hale M, Nasrabadi NN, Wolff DS, Vonk FJ, Kool J, Laustsen AH. Terrestrial venomous animals, the envenomings they cause, and treatment perspectives in the Middle East and North Africa. PLoS Negl Trop Dis. 2021 Dec 2;15(12):e0009880. doi: 10.1371/journal.pntd.0009880. eCollection 2021 Dec.
- Isbister GK. Snakebite doesn't cause disseminated intravascular coagulation: coagulopathy and thrombotic microangiopathy in snake envenoming. Semin Thromb Hemost. 2010 Jun;36(4):444-51. doi: 10.1055/s-0030-1254053. Epub 2010 Jul 7.
- Harris JB, Scott-Davey T. Secreted phospholipases A2 of snake venoms: effects on the peripheral neuromuscular system with comments on the role of phospholipases A2 in disorders of the CNS and their uses in industry. Toxins (Basel). 2013 Dec 17;5(12):2533-71. doi: 10.3390/toxins5122533.
- Bickler PE. Amplification of Snake Venom Toxicity by Endogenous Signaling Pathways. Toxins (Basel). 2020 Jan 22;12(2):68. doi: 10.3390/toxins12020068.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Snakebites in Assiut Governate
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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