NCT04845022

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
81

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 28, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 14, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

June 14, 2021

Status Verified

June 1, 2021

Enrollment Period

1.4 years

First QC Date

April 10, 2021

Last Update Submit

June 9, 2021

Conditions

Keywords

TMA, Peripheral blood smear(PBS)

Outcome Measures

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

    1 year

Secondary Outcomes (1)

  • To find the number of hematotoxic snakebites associated with thrombotic microangiopathy (TMA) cases within 7days of admission

    1 year

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jubilee Mission Medical College

Thrissur, Kerala, 680005, India

RECRUITING

MeSH Terms

Conditions

Snake BitesThrombotic MicroangiopathiesSickle Cell Trait

Condition Hierarchy (Ancestors)

Bites and StingsPoisoningChemically-Induced DisordersWounds and InjuriesThrombocytopeniaBlood Platelet DisordersHematologic DiseasesHemic and Lymphatic DiseasesCytopeniaAnemia, Sickle CellAnemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Aboobacker Rafi, MD

    Jubilee Mission Medical College and Research Institute

    STUDY CHAIR

Central Study Contacts

Maglin Tomy, MD

CONTACT

Dr.Siju Abraham

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Junior Resident

Study Record Dates

First Submitted

April 10, 2021

First Posted

April 14, 2021

Study Start

January 28, 2021

Primary Completion

June 30, 2022

Study Completion

January 1, 2023

Last Updated

June 14, 2021

Record last verified: 2021-06

Locations