Condition category
Injury, Occupational Diseases, Poisoning
Date applied
19/01/2009
Date assigned
28/01/2009
Last edited
28/01/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Kishore Pichamuthu

ORCID ID

Contact details

Medical ICU
Christian Medical College
Ida Scudder Road
Vellore
632004
India

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

http://www.sactrc.org

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

Publication citations

Additional files

Editorial Notes