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Clinical Trials/NCT02752256
NCT02752256CompletedNot Applicable

Quality and Effectiveness of Thrombolytic Care During Inter-hospital Transfer ("Drip-Ship") With Air Ambulance Services

University of Iowa1 site in 1 country76 target enrollmentStarted: October 2015Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
76
Locations
1
Primary Endpoint
Percentage of Participants With a rtPA Protocol Violation

Study Overview

Brief Summary

Evaluation of ischemic stroke patients receiving tissue plasminogen activator (rtPA) during air ambulance transfer

Detailed Description

The purpose of our study is to evaluate the effect of air ambulance transport on patients presenting with an ischemic stroke and receive tissue plasminogen activator (rtPA). Primary outcome will be the evaluation of air ambulance transfer and if it leads to protocol violations or significant delays in therapy. Protocol violations include inaccurate dosing or preparation at the outside hospital, uncontrolled blood pressure before and during the flight, unnecessary medication administration before and during the flight and adverse events (intracranial bleeding, allergic reaction) associated with transfer process. Additional evaluation will include the effects of vibration of the air ambulance and its effects on the lytic activity of rtPA. rtPA is not supposed to be significantly agitated after it is prepared in solution and there is significant vibration and agitation during air ambulance transfer.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Patients who received tissue plasminogen activator for acute ischemic stroke
  • presented directly to comprehensive stroke center or were transferred by our air ambulance service

Exclusion Criteria

  • Transferred by another air ambulance service or ground ambulance

Arms & Interventions

Intervention/Transfer

Patients who are transferred via air ambulance to a comprehensive stroke center

Intervention: Tissue Plasminogen Activator (Drug)

Control

Patients presenting directly to the comprehensive stroke center

Intervention: Tissue Plasminogen Activator (Drug)

Outcomes

Primary Outcomes

Percentage of Participants With a rtPA Protocol Violation

Time Frame: 24 hours

Protocol violations can include any of the following recorded outcomes: inaccurate dosing or preparation at the outside hospital, uncontrolled blood pressure before and during the flight, unnecessary medication administration before and during the flight, intracranial bleeding, and angioedema

Secondary Outcomes

  • Average Time to rtPA(24 hours)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Brett A Faine

Clinical Pharmacy Specialist

University of Iowa

Study Sites (1)

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