Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
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
Acronym
BIOSTOP
Study hypothesis
To evaluate the effect of administration of fresh frozen plasma and albumin separately, as bioscavenger therapy, on biochemical and clinical outcomes in patients presenting with acute organophosphate (OP) poisoning.
Ethics approval
Christian Medical College Vellore India ethics committee gave approval on the 23rd January 2007 (ref: RC Min No 6128)
Study design
Unblinded randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Organophosphate poisoning
Intervention
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 receive either FFP or albumin. Common treatment: atropine and sedation schedule. No oximes are given.
Follow-up consists of clinical assessment and laboratory measurement of outcome measures.
Intervention type
Drug
Phase
Not Applicable
Drug names
Fresh frozen plasma, albumin
Primary outcome measures
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
Secondary outcome measures
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
Overall trial start date
01/05/2007
Overall trial end date
03/03/2009
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant 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
Recruitment start date
01/05/2007
Recruitment end date
03/03/2009
Locations
Countries of recruitment
India
Trial participating centre
Medical ICU
Vellore
632004
India
Sponsor information
Organisation
South Asian Clinical Toxicology Research Collaboration (SACTRC) (Sri Lanka)
Sponsor details
Faculty of Medicine
Peradeniya University
Peradeniya
20400
Sri Lanka
+94 (0)81 447 9822
enquiry@sactrc.org
Sponsor type
Research organisation
Website
Funders
Funder type
Charity
Funder name
International Collaborative Research Grant:
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Wellcome Trust (UK) (grant ref: 071669)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
National Health and Medical Research Council (NHMRC) (Australia)
Alternative name(s)
NHMRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Australia
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary