BIOScavenger Therapy in Organophosphate Poisoning

ISRCTN	ISRCTN84835351
DOI	https://doi.org/10.1186/ISRCTN84835351
Secondary identifying numbers	N/A

Submission date: 19/01/2009
Registration date: 28/01/2009
Last edited: 28/01/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Kishore Pichamuthu
Scientific

Medical ICU
Christian Medical College
Ida Scudder Road
Vellore
632004
India

Study information

Study design	Unblinded randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study acronym	BIOSTOP
Study objectives	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(s)	Christian Medical College Vellore India ethics committee gave approval on the 23rd January 2007 (ref: RC Min No 6128)
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Fresh frozen plasma, albumin
Primary outcome measure	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 study start date	01/05/2007
Completion date	03/03/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	60
Key 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
Key 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
Date of first enrolment	01/05/2007
Date of final enrolment	03/03/2009

Locations

Countries of recruitment

India

Study participating centre

Medical ICU

Vellore
632004
India

Sponsor information

South Asian Clinical Toxicology Research Collaboration (SACTRC) (Sri Lanka)
Research organisation

Faculty of Medicine
Peradeniya University
Peradeniya
20400
Sri Lanka

Phone	+94 (0)81 447 9822
Email	enquiry@sactrc.org
Website	http://www.sactrc.org
"ROR"	https://ror.org/04z435g27

Funders

Funder type

Charity

International Collaborative Research Grant:

No information available

The Wellcome Trust (UK) (grant ref: 071669)

No information available

National Health and Medical Research Council (NHMRC) (Australia)
Government organisation / National government

Alternative name(s): NHMRC
Location: Australia

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan