Cyanide PoisoningNCT01656616
Hydroxycobalamin and Rural Emergency Medical Services Cyanide Exposure Patients: A Cost Analysis
An observational study of Cyanide Poisoning, run by MaineHealth at 1 site in United States.
Trial summary
The costs to a rural emergency medical services (EMS) system of a change from a traditional cyanide antidote kit to a kit containing hydroxocobalamin alone are currently unknown. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cyanide Poisoning
- What is being tested?
- Cyanide antidote administration
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2012to 1 Aug 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: EMS patients possibly exposed to cyanide via poisoning or smoke exposure.
Who may be able to join
- Included in Maine EMS database
- House Fire Victim
- Poisoning
Who cannot join
- No potential cyanide exposure
- Incomplete data available
Trial locations and contacts
1 site in 1 country.
United States1 site
Maine Medical Center Department of Emergency Medicine
Portland, Maine, 04102
About this study
The costs to a rural emergency medical services (EMS) system of a change from a traditional cyanide antidote kit to a kit containing hydroxocobalamin alone are currently unknown. The purpose of this study is to use current EMS data to calculate the costs to a rural EMS system associated with the adoption of a hydroxocobalamin protocol for the treatment of suspected cyanide exposure.
- Conditions
- Cyanide Poisoning
- Being tested
- Cyanide antidote administration
- Keywords
- Pharmacoeconomics, Cost effectiveness, Cyanide, Fire, Emergency Medical Services, Smoke Inhalation
- Medical subject headings
- Smoke Inhalation Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyanide antidote administrationDrug
| Study group | Role | What they receive |
|---|---|---|
| EMS cyanide exposure patients | Not described Receives: Drug: Cyanide antidote administration |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2012 (estimated)
- Study start1 Aug 2012
- Primary completion1 Aug 2012
- Study completion1 Aug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cyanide PoisoningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- MaineHealth
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katrina G. Ferguson, MaineHealth
- Investigators
- Tania D Strout, PhD, RN, MS, Study director, MaineHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01656616
- Sponsor's protocol ID
- IRB 4053X
- Status last verified
- May 2017
- First submitted
- 1 Aug 2012
- Last updated
- 18 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydroxycobalamin and Rural Emergency Medical Services Cyanide Exposure Patients: A Cost Analysis
- ClinicalTrials.gov ID
- NCT01656616
- Acronym / sponsor ID
- IRB 4053X
- Conditions
- Cyanide Poisoning
- Keywords
- Pharmacoeconomics, Cost effectiveness, Cyanide, Fire, Emergency Medical Services, Smoke Inhalation
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- MaineHealthUniversity, hospital or other
- Study start
- 1 Aug 2012 (actual)
- Primary completion
- 1 Aug 2012 (actual)
- Study completion
- 1 Aug 2012 (actual)
- First posted
- 3 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The costs to a rural emergency medical services (EMS) system of a change from a traditional cyanide antidote kit to a kit containing hydroxocobalamin alone are currently unknown. The purpose of this study is to use current EMS data to calculate the costs to a rural EMS system associated with the adoption of a hydroxocobalamin protocol for the treatment of suspected cyanide exposure.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EMS cyanide exposure patients | – | Drug: Cyanide antidote administration |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- EMS patients possibly exposed to cyanide via poisoning or smoke exposure.
Key inclusion criteria (3 listed)
- Included in Maine EMS database
- House Fire Victim
- Poisoning
Key exclusion criteria (2 listed)
- No potential cyanide exposure
- Incomplete data available
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cyanide antidote administration | Drug | EMS cyanide exposure patients |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tania D Strout, PhD, RN, MS study director
MaineHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cyanide Poisoning, run by MaineHealth at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2017.