Out-of-hospital Cardiac ArrestSHARENCT01999036
Save Hearts in Arizona Registry and Education (SHARE) Project
An observational study of Out-of-hospital Cardiac Arrest, run by University of Arizona at 1 site in United States.
Trial summary
Evaluation of the impact of bystander CPR, prehospital resuscitation protocols, and hospital post-resuscitation protocols for out-of-hospital cardiac arrest patients in the state of Arizona. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Out-of-hospital Cardiac Arrest
- How many people
- 20,000 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to Jan 2020
- 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: Out-of-hospital cardiac arrest patients on which resuscitation was attempted by Emergency Medical Services in the state of Arizona
Who may be able to join
- Out of Hospital Cardiac Arrest (loss of spontaneous circulation and EMS attempted resuscitation)
Who cannot join
- Do Not Resuscitate
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Study site
Multiple Locations, Arizona
Bentley Bobrow, MD, 602-364-3154, bentley.bobrow@azdhs.gov
Bentley Bobrow, MD
About this study
Evaluation of the impact of bystander CPR, prehospital resuscitation protocols, and hospital post-resuscitation protocols for out-of-hospital cardiac arrest patients in the state of Arizona.
- Conditions
- Out-of-hospital Cardiac Arrest
- Keywords
- cardiac arrest, CPR, resuscitation
- Medical subject headings
- Out-of-Hospital Cardiac Arrest, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Resuscitation of OHCA | Resuscitation of out-of-hospital cardiac arrest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival to hospital discharge
Patients will be followed for the duration of hospital stay. The average time from admission to either discharge or death is expected to be approximately 2 weeks.
Measured: Upon hospital discharge and annually up to 5 years
Secondary outcomes (1)
Emergency Medical Services Cardiopulmonary Resuscitation (CPR) quality
Chest compression depth, rate, recoil, fraction. Patients will be followed for the duration of prehospital resuscitation. The average timeframe is expected to be approximately 15 minutes.
Measured: Prehospital resuscitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2013 (estimated)
- Study startNov 2004
- Primary completionJan 2020 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Out-of-hospital Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- Arizona Department of Health Services
- Responsible party
- Principal investigator, Bentley J. Bobrow, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01999036
- Sponsor's protocol ID
- 11-0046
- Acronym
- SHARE
- Status last verified
- May 2018
- First submitted
- 18 Oct 2013
- Last updated
- 9 May 2018
- Results posted
- No
Publications
Irisawa T, Vadeboncoeur TF, Karamooz M, Mullins M, Chikani V, Spaite DW, Bobrow BJ. Duration of Coma in Out-of-Hospital Cardiac Arrest Survivors Treated With Targeted Temperature Management. Ann Emerg Med. 2017 Jan;69(1):36-43. doi: 10.1016/j.annemergmed.2016.04.021. Epub 2016 May 27.
PubMed 27238827
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Save Hearts in Arizona Registry and Education (SHARE) Project
- ClinicalTrials.gov ID
- NCT01999036
- Acronym / sponsor ID
- SHARE / 11-0046
- Conditions
- Out-of-hospital Cardiac Arrest
- Keywords
- cardiac arrest, CPR, resuscitation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- Arizona Department of Health Services
- Study start
- Nov 2004
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 3 Dec 2013 (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.
Evaluation of the impact of bystander CPR, prehospital resuscitation protocols, and hospital post-resuscitation protocols for out-of-hospital cardiac arrest patients in the state of Arizona.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Resuscitation of OHCA | – | –Resuscitation of out-of-hospital cardiac arrest |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Out-of-hospital cardiac arrest patients on which resuscitation was attempted by Emergency Medical Services in the state of Arizona
Key inclusion criteria (1 listed)
- Out of Hospital Cardiac Arrest (loss of spontaneous circulation and EMS attempted resuscitation)
Key exclusion criteria (1 listed)
- Do Not Resuscitate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Survival to hospital discharge
Time frame: Upon hospital discharge and annually up to 5 years
Patients will be followed for the duration of hospital stay. The average time from admission to either discharge or death is expected to be approximately 2 weeks.
1 secondary outcome
Emergency Medical Services Cardiopulmonary Resuscitation (CPR) quality
Time frame: Prehospital resuscitation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2018.
- Derived from this study: PubMed 27238827Irisawa T, Vadeboncoeur TF, Karamooz M, Mullins M, Chikani V, Spaite DW, Bobrow BJ. Duration of Coma in Out-of-Hospital Cardiac Arrest Survivors Treated With Targeted Temperature Management. Ann Emerg Med. 2017 Jan;69(1):36-43. doi: 10.1016/j.annemergmed.2016.04.021. Epub 2016 May 27.
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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.
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 Out-of-hospital Cardiac Arrest, run by University of Arizona 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 9 May 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival to hospital discharge (time frame: Upon hospital discharge and annually up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01999036, which also lists 1 linked publication.
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 9 May 2018.