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

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.

Study Overview

• Status: Recruiting
• Conditions: SNAKEBITE; THROMBOTIC MICROANGIOPATHY; SCHISTOCYTES

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 Type: Observational
• Enrollment (Anticipated): 81

Contacts and Locations

• Study Contact: Name: Maglin Tomy, MD; Phone Number: 9895731303; Email: maglinmonica@gmail.com
• Study Contact Backup: Name: Dr.Siju Abraham; Phone Number: 9447754321; Email: sijuvabraham@jmmc.ac.in

Study Locations

• India
  • Kerala
    • Thrissur, Kerala, India, 680005
      • Recruiting
      • Jubilee Mission Medical College
      • Contact: Maglin Monica Lisa Tomy, MBBS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All snakebite victims who meet the inclusion criteria would be included in the study

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Jubilee Mission Medical College and Research Institute
• Investigators: Study Chair: Aboobacker Rafi, MD, Jubilee Mission Medical College and Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2021
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): January 1, 2023

Study Registration Dates

• First Submitted: April 10, 2021
• First Submitted That Met QC Criteria: April 10, 2021
• First Posted (Actual): April 14, 2021

Study Record Updates

• Last Update Posted (Actual): June 14, 2021
• Last Update Submitted That Met QC Criteria: June 9, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: TMA, Peripheral blood smear(PBS)
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Cardiovascular Diseases; Wounds and Injuries; Hematologic Diseases; Thrombocytopenia; Blood Platelet Disorders; Poisoning; Bites and Stings; Vascular Diseases; Thrombotic Microangiopathies; Snake Bites
• Other Study ID Numbers: 16/21/IEC/JMMC&RI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No