CClinicalTrials.gg
Status unknownNCT04845022Updated Jun 14, 2021

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

An observational study in SNAKEBITE, THROMBOTIC MICROANGIOPATHY and SCHISTOCYTES, sponsored by Jubilee Mission Medical College and Research Institute. Status unknown at 1 site in India. Per ClinicalTrials.gov, last updated 2021-06-14.

Sponsored by Jubilee Mission Medical College and Research Institute · Observational

The sponsor has not verified this record recently (last verified Jun 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
81
Sex
All
01

Study 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.

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.

02

Conditions studied

  • SNAKEBITE
  • THROMBOTIC MICROANGIOPATHY
  • SCHISTOCYTES

Keywords

  • TMA, Peripheral blood smear(PBS)
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

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
04

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
81 participants (estimated)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. 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

    Time frame: 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

    Time frame: 1 year

06

Study locations

1 of 1 sites recruiting
  • Jubilee Mission Medical College
    Thrissur, Kerala 680005, India
    • Maglin Monica Lisa Tomy, MBBS · Contact
    Recruiting
07

Registry details

Key details

Study ID
NCT04845022
Lead sponsor
Jubilee Mission Medical College and Research Institute
Responsible party
MAGLIN TOMY (Junior Resident, Jubilee Mission Medical College and Research Institute) — Principal investigator
First posted
Apr 14, 2021
Start date
Jan 28, 2021
Primary completion
Jun 30, 2022 (estimated)
Completion
Jan 1, 2023 (estimated)
Last update
Jun 14, 2021

Study contacts

Maglin Tomy, MD
Contact
maglinmonica@gmail.com
9895731303
Dr.Siju Abraham
Contact
sijuvabraham@jmmc.ac.in
9447754321
Aboobacker Rafi, MD
study chair · Jubilee Mission Medical College and Research Institute

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion