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BIOScavenger Therapy in Organophosphate Poisoning

Open-label three-arm randomised controlled trial of fresh frozen plasma and albumin in the treatment of organophosphate poisoning: the BioSTOP (BIOScavenger Therapy in Organophosphate Poisoning) study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN84835351
Enrollment
60
Registered
2009-01-28
Start date
2007-05-01
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Organophosphate poisoning Injury, Occupational Diseases, Poisoning Toxic effect of pesticides

Interventions

Treatment arms: 1. Fresh frozen plasma (FFP) (250 ml/bag): 4 bags on day 1 then 2 bags on day 2 and 3 2. 20% human albumin: 200 ml intravenous on day 1 then 100 ml on day 2 and 3 3. Control: do not

Sponsors

South Asian Clinical Toxicology Research Collaboration (SACTRC) (Sri Lanka)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients (both males and females) above 15 years who present to the Emergency Department of Christian Medical College and Hospital (CMCH) with a diagnosis of organophosphate poisoning made on the basis of: 1. The typical clinical toxidrome of cholinergic and nicotinic manifestations 2. Reliable identification of the compound ingested based on the container brought by patient attendants or a subsequent confirmation by serum pseudocholinesterase levels of less than 1000 IU/L

Exclusion criteria

Exclusion criteria: 1. Those who present more than 12 hours after having consumed the OP poison ("late presenters") 2. Those who are suspected to have taken a combination of poisons/tablets along with the OP ("poly-substance overdose") 3. Those who are already treated with oximes in other hospitals prior to coming here ("prior oxime therapy"). This is because we do not want to have more than one intervention which can affect outcomes. 4. Those who are pregnant or lactating 5. Those who do not give consent for the study 6. Those who have a pre-existing volume overloaded state 7. Those who have a cardiac arrest within 15 minutes of arrival in the emergency department

Design outcomes

Secondary

MeasureTime frame
All measured during hospital stay and determined at discharge: 1. Reduce the need for invasive mechanical ventilation 2. Reduce mortality 3. Decrease Intensive Care Unit (ICU)/hospital length of stay 4. Reduce the duration of ventilation 5. The total dose of atropine required (daily and cumulative) 6. Temporal profile of organophosphate levels (total and functional), serum butyrylcholinesterase (BuChE) level 7. Adverse events and transfusion reactions

Primary

MeasureTime frame
1. Lower the incidence of intermediate syndrome, measured during hospital stay and determined at discharge 2. Reduce effective circulating organophosphate levels, assayed directly and functionally and measured directly after the infusion of trial or placebo interventions

Countries

India

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026