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

NCT ID: NCT04845022

Last Updated: 2021-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

81 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-28

Study Completion Date

2023-01-01

Brief Summary

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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

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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

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SNAKEBITE THROMBOTIC MICROANGIOPATHY SCHISTOCYTES

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* All patients with a history of snakebite and with prolonged WBCT.

Exclusion Criteria

* 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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jubilee Mission Medical College and Research Institute

OTHER

Sponsor Role lead

Responsible Party

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MAGLIN TOMY

Junior Resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aboobacker Rafi, MD

Role: STUDY_CHAIR

Jubilee Mission Medical College and Research Institute

Locations

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Jubilee Mission Medical College

Thrissur, Kerala, India

Site Status RECRUITING

Countries

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India

Central Contacts

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Maglin Tomy, MD

Role: CONTACT

9895731303

Dr.Siju Abraham

Role: CONTACT

9447754321

Facility Contacts

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Maglin Monica Lisa Tomy, MBBS

Role: primary

Other Identifiers

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16/21/IEC/JMMC&RI

Identifier Type: -

Identifier Source: org_study_id

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