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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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
SLCTR
Registry ID
SLCTR/2024/008
Enrollment
Unknown
Registered
2024-03-15
Start date
2024-03-15
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Snakebite associated thrombotic microangiopathy

Interventions

Study setting: At five hospitals
NHSL -Colombo, TH Peradeniya, NHSL- Kandy, TH Anuradhapura, and TH Kurunegala. Study population: All patients who have been bitten by a RV (Russell's Viper) or HNV (Humped No

Sponsors

None listed

Eligibility

Inclusion criteria

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 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

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

Design outcomes

Primary

MeasureTime frame
"Survival" defined as whether the patient is alive or deceased at the three-month mark. Tool used: Medical records or direct follow up [At the time of discharge and 3 months after discharge from the hospital ] "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 ] Glomerular filtration rate (eGFR) <30 ml/min/1.73m2 [An eGFR <30 ml/min/1.73m2 signifies severe kidney dysfunction] [ At the time of discharge and 3 months after discharge from the hospital ]

Secondary

MeasureTime frame
Number of blood transfusions [At the time of discharge from the hospital ] Number of dialysis received [ At the time of discharge from the hospital ] Duration of the hospital stay [ At the time of discharge from the hospital ]

Countries

Sri Lanka

Contacts

Public ContactProfessor Eranga Wijewickrama

Professor

erangasw@clinmed.cmb.ac.lk

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026