A Multicenter, open-labelled, randomized controlled trial to evaluate the efficacy and safety of therapeutic plasma exchange in subjects with snakebite associated thrombotic microangiopathy compared to those receiving standard of care alone

Not Applicable

• Conditions: Snakebite associated thrombotic microangiopathy

• Registration Number: SLCTR/2024/008

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 20 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

1.All males and females
2. All patients with age equal to more than 18 years
2.Patients diagnosed with TMA with or without AKI following RV or HNV bite
3.Patients directly admitted or transferred to the hospital within 5 days of the snakebite

Criteria used for diagnosis of TMA:
TMA is confirmed by the presence of microangiopathic haemolytic anaemia (MAHA) with > 1.0%
schistocytes in peripheral blood film examination with absolute thrombocytopenia < 150 x 109 /L or
> 25% reduced platelet count from baseline, with or without AKI.
At each study site, the local hematologists will be provided with a protocol to identify TMA by
recognizing and calculating schistocytes in the peripheral blood

Exclusion Criteria

1. Patients having known allergy to drug prodcuts
2.Pregnancy
3.Patients having allergic reactions to blood products
4.Patients with pre-existing chronic kidney disease with an eGFR <30 ml/min/1.73m2

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival defined as whether the patient is alive or deceased at the three-month mark.<br><br>Tool used: Medical records or direct follow up<br><br> <br> [At the time of discharge and 3 months after discharge from the hospital ]<br> Dialysis dependency defined as whether the patient requires ongoing dialysis treatments for kidney function [ At the time of discharge and 3 months after discharge from the hospital ]<br>Glomerular filtration rate (eGFR) <30 ml/min/1.73m2 <br> [An eGFR <30 ml/min/1.73m2 signifies severe kidney dysfunction] [ At the time of discharge and 3 months after discharge from the hospital ]<br>

Secondary Outcome Measures

Name	Time	Method
umber of blood transfusions [At the time of discharge from the hospital ]<br> Number of dialysis received [ At the time of discharge from the hospital ]<br> Duration of the hospital stay [ At the time of discharge from the hospital ]<br>