Snakebite Cases Evaluation Clinical and LaboratoryNCT06703645
Evaluation of Snakebite Cases in Assiut Governorate, Egypt (Prospective Study)
An observational study of Snakebite Cases Evaluation Clinical and Laboratory, run by Assiut University.
Trial summary
1. Study the sociodemographic profile of snakebite victims in Assiut Governorate. 2. Portray the clinical profile of snakebite victims admitted to Assiut University , El Eman General Hospital and Assiut General Hospital. 3. Assess the predictors of severity and outcome of cases. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Snakebite Cases Evaluation Clinical and Laboratory
- How many people
- 49 participants
- Where
- No sites listed yet
- Study dates
- 30 Dec 2024to 30 Jan 2026
- How long will I take part?
- 10 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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: 1. 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. 2. 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
Who may be able to join
- Patients admitted with a reliable history of snakebite.
- Presence of fang marks and/or signs of local and systemic envenomation.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this 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.
Read the 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.
- Keywords
- snakebite
- Medical subject headings
- Snake Bites
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with recovery
- Number of Participants with complete recovery.
- Number of Participants with recovery with disability and complications as amputation and renal failure, etc.
Measured: through study completion, an average of 1 year".
Number of Participants with Death
Any complication due to snake bite end with death as respiratory arrest, disseminated intravascular coagulation and renal failure.
Measured: through study completion, an average of 1 year".
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start30 Dec 2024 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Snakebite Cases Evaluation Clinical and LaboratoryStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 49 participants (estimated)
- Target duration
- 10 Days
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Alkady Mohamed, Assiut University
- Investigators
- Hala Mohammed Fathy, Professor, Study director, Assiut UniversityNora Zeidan Abdellah, Assistant lecture, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06703645
- Sponsor's protocol ID
- Snakebites in Assiut Governate
- Status last verified
- Nov 2024
- First submitted
- 17 Nov 2024
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 30341870Namal 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.
PubMed 30711421Langley 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.
PubMed 33005969Kumar 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.
PubMed 29892202Kang 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.
PubMed 27752613Jenkins 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.
PubMed 34855751Isbister 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.
PubMed 20614396Harris 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.
PubMed 24351716Bickler PE. Amplification of Snake Venom Toxicity by Endogenous Signaling Pathways. Toxins (Basel). 2020 Jan 22;12(2):68. doi: 10.3390/toxins12020068.
PubMed 31979014
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Snakebite Cases in Assiut Governorate, Egypt (Prospective Study)
- ClinicalTrials.gov ID
- NCT06703645
- Acronym / sponsor ID
- Snakebites in Assiut Governate
- Keywords
- snakebite
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Dec 2024 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 25 Nov 2024 (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.
- 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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 10 Days
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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: 1. 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. 2. 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
Key inclusion criteria (2 listed)
- Patients admitted with a reliable history of snakebite.
- Presence of fang marks and/or signs of local and systemic envenomation.
Key exclusion criteria (3 listed)
- 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.
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
Number of Participants with recovery
Time frame: through study completion, an average of 1 year".
1. Number of Participants with complete recovery. 2. Number of Participants with recovery with disability and complications as amputation and renal failure, etc.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Results publication: PubMed 30341870Padhiyar 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.
- Results publication: PubMed 30711421Namal 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.
- Results publication: PubMed 33005969Langley 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.
- Results publication: PubMed 29892202Kumar 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.
- Results publication: PubMed 27752613Kang 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.
- Results publication: PubMed 34855751Jenkins 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.
- Results publication: PubMed 20614396Isbister 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.
- Results publication: PubMed 24351716Harris 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.
- Results publication: PubMed 31979014Bickler PE. Amplification of Snake Venom Toxicity by Endogenous Signaling Pathways. Toxins (Basel). 2020 Jan 22;12(2):68. doi: 10.3390/toxins12020068.
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.
Hala Mohammed Fathy, Professor study director
Assiut University
Nora Zeidan Abdellah, Assistant lecture study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Snakebite Cases Evaluation Clinical and Laboratory, run by Assiut University.
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 2 inclusion and 3 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: opening soon, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rania Alkady Mohamed, demonstrator (01153387577, raniaalkady4@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with recovery (time frame: through study completion, an average of 1 year".). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06703645, which also lists 9 linked publications.
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 25 Nov 2024.