Hydroxycobalamin and Rural Emergency Medical Services Cya... | NCT01656616

Studies
Hydroxycobalamin and Rural Emergency Medical Services Cyanide Exposure Patients: A Cost Analysis

NCT01656616

Sponsor

MaineHealth

Status

Withdrawn

Last Update Posted

May 18, 2017Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Cyanide Poisoning

Interventions

Cyanide antidote administration

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2012Actual

Primary Completion Date

Aug 1, 2012Actual

Completion Date

Aug 1, 2012Actual

First Submitted Date

Aug 1, 2012

First Submission Date that Met QC Criteria

Aug 2, 2012

First Posted Date

Aug 3, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 16, 2017

Last Update Posted Date

May 18, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Katrina G. Ferguson, Director of Research, Department of Emergency Medicine, MaineHealthPrincipal Investigator

Lead Sponsor

MaineHealthOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Label	Type	Description	Intervention Names
EMS cyanide exposure patients			Drug: Cyanide antidote administration

Name	Type	Description	Arm Group Labels	Other Names
Cyanide antidote administration	Drug		EMS cyanide exposure patients

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Included in Maine EMS database
House Fire Victim
Poisoning

Exclusion Criteria:

No potential cyanide exposure
Incomplete data available

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

EMS patients possibly exposed to cyanide via poisoning or smoke exposure.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tania D Strout, PhD, RN, MS	MaineHealth	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maine Medical Center Department of Emergency Medicine		Portland	Maine	04102	United States

Condition Browse Module

MeSH Terms

ID	Term
D015208	Smoke Inhalation Injury

Ancestor Terms

ID	Term
D002059	Burns, Inhalation
D002056	Burns
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided