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

THROMBOTIC MICROANGIOPATHY Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04845022
• Other study ID #: 16/21/IEC/JMMC&RI
• Status: Recruiting
• Start date: January 28, 2021
• Est. completion date: January 1, 2023

Study information

• Verified date: June 2021
• Source: Jubilee Mission Medical College and Research Institute
• Contact: Maglin Tomy, MD
• Phone: 9895731303
• Email: maglinmonica[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 81
• Est. completion date: January 1, 2023
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• SCHISTOCYTES
• Snake Bites
• SNAKEBITE
• Thrombotic Microangiopathies
• THROMBOTIC MICROANGIOPATHY
• Vascular Diseases

Locations

Country	Name	City	State
India	Jubilee Mission Medical College	Thrissur	Kerala

Sponsors (1)

Lead Sponsor	Collaborator
Jubilee Mission Medical College and Research Institute

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 year
Secondary	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	1 year