Study Stopped
DSMB recommended termination due to lower survival to discharge in primary population and worse discharge CPC scores in the treatment arm than control arm.
AutoPulse Assisted Prehospital International Resuscitation Trial (ASPIRE)
1 other identifier
interventional
1,837
1 country
1
Brief Summary
The AutoPulse Assisted Prehospital International Resuscitation (ASPIRE) Trial compares the efficacy of circulatory assist by manual chest compression versus an automated chest compression device (AutoPulse™) during the resuscitative attempt following out-of-hospital cardiac arrest.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2004
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
June 30, 2005
CompletedFirst Posted
Study publicly available on registry
July 19, 2005
CompletedJanuary 27, 2011
January 1, 2011
June 30, 2005
January 26, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hospital admission defined as being alive four hours after the call for assistance to the emergency dispatch center.
Secondary Outcomes (6)
ROSC (a pulse in any vessel) at any time
ROSC at arrival to emergency department
Admittance to the hospital
Discharge from the hospital
CPC score at discharge from the hospital
- +1 more secondary outcomes
Study Arms (2)
1
EXPERIMENTALAutopulse device
2
ACTIVE COMPARATORManual CPR
Interventions
Eligibility Criteria
You may qualify if:
- All persons with out-of-hospital cardiac arrest who are attended by a vehicle involved in the randomization process and who are treated by the emergency medical service (EMS).
You may not qualify if:
- Persons under the age of 18
- Victims with traumatic arrest
- Less than the legal age of consent
- Resuscitation attempt discontinued because of do not resuscitate (DNR) orders or on request of authorized decision-maker
- Wards of the state, including prisoners
- Chest or abdominal surgery within 6 weeks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Washingtonlead
- Revivant Corporationcollaborator
Study Sites (1)
University of Washington Clinical Trial Center
Seattle, Washington, 98105, United States
Related Publications (2)
Hallstrom A, Rea TD, Sayre MR, Christenson J, Anton AR, Mosesso VN Jr, Van Ottingham L, Olsufka M, Pennington S, White LJ, Yahn S, Husar J, Morris MF, Cobb LA. Manual chest compression vs use of an automated chest compression device during resuscitation following out-of-hospital cardiac arrest: a randomized trial. JAMA. 2006 Jun 14;295(22):2620-8. doi: 10.1001/jama.295.22.2620.
PMID: 16772625RESULTParadis NA, Young G, Lemeshow S, Brewer JE, Halperin HR. Inhomogeneity and temporal effects in AutoPulse Assisted Prehospital International Resuscitation--an exception from consent trial terminated early. Am J Emerg Med. 2010 May;28(4):391-8. doi: 10.1016/j.ajem.2010.02.002.
PMID: 20466215DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alfred P. Hallstrom, PhD
University of Washington
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 30, 2005
First Posted
July 19, 2005
Study Start
June 1, 2004
Study Completion
March 1, 2005
Last Updated
January 27, 2011
Record last verified: 2011-01