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Trials - SLCTR/2023/002

Protocol Change

Date

2025-07-20


Protocol

Protocol changed


Item Changed

Inclusion criteria


Previous Version

• Any patient of either sex, • Age between 18 and 60 years • Patients reporting with a history of confirmed snakebite, • SL-ASV will be administered only for systemic envenoming effects except local manifestations of confirmed cobra bites. The systemic envenoming effects are as follows: 1. Neurotoxic envenomation- Patients with ptosis, external ophthalmoplegia and respiratory failure 2. Haemotoxic envenomation- Patient presenting with bleeding manifestations with laboratory confirmation of coagulopathy such as WBCT >20 minutes (Whole Blood Clotting Test), elevated PT/INR and APTT. Local effects are as follows: 1. Patients presenting with local pain, swelling and necrosis following only confirmed cobra bites. • Following are the criteria/indications for giving SLASV for hump- nosed viper bites 1 Patients with positive WBCT20 and or elevated PT/INR (VICC) 2. Patients with oliguria/anuria (UOP < 0.5 mL/kg/hr for 6 hrs) or increased serum creatinine (> 27 ?mol/L relative to a known baseline value within 48 hrs/ or clinical diagnosis) [acute kidney injury]


Next Version

•Any patient of either sex, aged between 18 and 60 years reporting a history of confirmed snakebite. AVS will be administered only for systemic envenomation, and local manifestations of confirmed cobra bites. •Neurotoxic envenomation- Patients with ptosis, external ophthalmoplegia, diplopia, dysphonia, respiratory failure, not being able to complete a sentence and a single breath count of < 30 numbers •Hemotoxic envenomation- Patient presenting with bleeding manifestations with laboratory confirmation of coagulopathy such as WBCT >20 minutes (Whole Blood Clotting Test), elevated PT/INR and APTT. •Local effects: Patients presenting with local pain, swelling and necrosis following only for confirmed cobra bites •Patient or his/her Legally Acceptable Representative (LAR) willing to provide informed consent • Following are the criteria/indications for giving SLASV for hump- nosed viper bites 1 Patients with positive WBCT20 and or elevated PT/INR (VICC) 2. Patients with oliguria/anuria (UOP < 0.5 mL/kg/hr for 6 hrs) or increased serum creatinine (> 27 ?mol/L relative to a known baseline value within 48 hrs/ or clinical diagnosis) [acute kidney injury]