SNAKEBITENCT04845022
Incidence of Snakebite Associated Thrombotic Microangiopathy & Role of Peripheral Blood Smear as a Predictor of Clinical Outcome
An observational study of SNAKEBITE and THROMBOTIC MICROANGIOPATHY, run by Jubilee Mission Medical College and Research Institute at 1 site in India.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- SNAKEBITE, THROMBOTIC MICROANGIOPATHY, SCHISTOCYTES
- How many people
- 81 participants
- Where
- 1 siteIndia
- Study dates
- 28 Jan 2021to 1 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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: All snakebite victims who meet the inclusion criteria would be included in the study
Who may be able to join
- All patients with a history of snakebite and with prolonged WBCT.
Who cannot join
- Patients administered with blood or blood components prior to admission
- Known case of bleeding disorders
- Known case of haemolytic anaemia
- Patients on antiplatelets or anticoagulants
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Jubilee Mission Medical College
Thrissur, Kerala, 680005
Maglin Monica Lisa Tomy, MBBS
About this study
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.
Read the detailed description
All snakebite patients brought to emergency department with history of bite and prolonged whole blood clotting time (WBCT) will be included in the study . their samples for hemogram, RFT and LDH would be collected in corresponding tubes . from sample for hemogram a peripheral blood smear (PBS) would be prepared , also the sample would be checked for direct coomb's test (DCT) positivity. DCT positive patients would be excluded from study . Also patients who received blood or blood components from outside hospital or patients with known history of hemolytic disease or patients on anti platelets or anticoagulants would also be excluded from this study .
thus patients who meet the exclusion and inclusion criteria would be followed up after 48 hours and their hemogram , RFT and LDH would be re assessed to check for presence of hemolysis , thrombocytopenia and acute kidney injury(AKI) .From the hemogram sample PBS would be prepared to check for presence of schistocytes.
Here we aim to study for incidence of TMA - defined as presence of MAHA( microangiopathic hemolytic anemia ) , thrombocytopenia and presence of AKI . MAHA is detected as drop of hb, presence of schistocytes in PBS , increase in LDH and increase in retic count. India is a tropical country and the southern state of Kerala , this study is done with the purpose of finding the prevalence of TMA among patients of snakebite brought to a tertiary care centre. Most often the victims are farmers or people from middle class. A cost effective test such as peripheral smear can help in predicting the prognosis and thereby aid in deciding whether the patient should require a multi disciplinary treatment early on and thereby play a pivotal role in saving patient life as well as provide an economical solution.
- Conditions
- SNAKEBITE, THROMBOTIC MICROANGIOPATHY, SCHISTOCYTES
- Keywords
- TMA, Peripheral blood smear(PBS)
- Medical subject headings
- Snake Bites, Thrombotic Microangiopathies, Sickle Cell Trait
What is being measured
The primary outcome is the main question the study is designed to answer.
To find the number of peripheral smear samples of TMA snakebite in which schistocyte grading helps in predicting the patient clinical outcome
To find the number of PBS smears in which morphological evaluation of RBC in PBS examination helps in predicting clinical outcome in snakebite associated TMA
Measured: 1 year
Secondary outcomes (1)
To find the number of hematotoxic snakebites associated with thrombotic microangiopathy (TMA) cases within 7days of admission
To find the number of TMA amongst snakebite victims in population coming to a tertiary care center in Kerala
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2021
- Study start28 Jan 2021
- Primary completion30 Jun 2022 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SNAKEBITEStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jubilee Mission Medical College and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MAGLIN TOMY, Jubilee Mission Medical College and Research Institute
- Investigators
- Aboobacker Rafi, MD, Study chair, Jubilee Mission Medical College and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04845022
- Sponsor's protocol ID
- 16/21/IEC/JMMC&RI
- Status last verified
- Jun 2021
- First submitted
- 10 Apr 2021
- Last updated
- 14 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Snakebite Associated Thrombotic Microangiopathy & Role of Peripheral Blood Smear as a Predictor of Clinical Outcome
- ClinicalTrials.gov ID
- NCT04845022
- Acronym / sponsor ID
- 16/21/IEC/JMMC&RI
- Conditions
- SNAKEBITE, THROMBOTIC MICROANGIOPATHY, SCHISTOCYTES
- Keywords
- TMA, Peripheral blood smear(PBS)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- Jubilee Mission Medical College and Research InstituteUniversity, hospital or other
- Study start
- 28 Jan 2021 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 14 Apr 2021 (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.
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.
Detailed description
All snakebite patients brought to emergency department with history of bite and prolonged whole blood clotting time (WBCT) will be included in the study . their samples for hemogram, RFT and LDH would be collected in corresponding tubes . from sample for hemogram a peripheral blood smear (PBS) would be prepared , also the sample would be checked for direct coomb's test (DCT) positivity. DCT positive patients would be excluded from study . Also patients who received blood or blood components from outside hospital or patients with known history of hemolytic disease or patients on anti platelets or anticoagulants would also be excluded from this study .
thus patients who meet the exclusion and inclusion criteria would be followed up after 48 hours and their hemogram , RFT and LDH would be re assessed to check for presence of hemolysis , thrombocytopenia and acute kidney injury(AKI) .From the hemogram sample PBS would be prepared to check for presence of schistocytes.
Here we aim to study for incidence of TMA - defined as presence of MAHA( microangiopathic hemolytic anemia ) , thrombocytopenia and presence of AKI . MAHA is detected as drop of hb, presence of schistocytes in PBS , increase in LDH and increase in retic count. India is a tropical country and the southern state of Kerala , this study is done with the purpose of finding the prevalence of TMA among patients of snakebite brought to a tertiary care centre. Most often the victims are farmers or people from middle class. A cost effective test such as peripheral smear can help in predicting the prognosis and thereby aid in deciding whether the patient should require a multi disciplinary treatment early on and thereby play a pivotal role in saving patient life as well as provide an economical solution.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All snakebite victims who meet the inclusion criteria would be included in the study
Key inclusion criteria (1 listed)
- All patients with a history of snakebite and with prolonged WBCT.
Key exclusion criteria (4 listed)
- Patients administered with blood or blood components prior to admission
- Known case of bleeding disorders
- Known case of haemolytic anaemia
- Patients on antiplatelets or anticoagulants
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
To find the number of peripheral smear samples of TMA snakebite in which schistocyte grading helps in predicting the patient clinical outcome
Time frame: 1 year
To find the number of PBS smears in which morphological evaluation of RBC in PBS examination helps in predicting clinical outcome in snakebite associated TMA
1 secondary outcome
To find the number of hematotoxic snakebites associated with thrombotic microangiopathy (TMA) cases within 7days of admission
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2021.
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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. This study is not recruiting at the moment.
Aboobacker Rafi, MD study chair
Jubilee Mission Medical College and Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SNAKEBITE and THROMBOTIC MICROANGIOPATHY, run by Jubilee Mission Medical College and Research Institute at 1 site in India.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 14 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maglin Tomy, MD (9895731303, maglinmonica@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To find the number of peripheral smear samples of TMA snakebite in which schistocyte grading helps in predicting the patient clinical outcome (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jun 2021.