Thrombolytic Care During Inter-hospital Transfer

June 28, 2019 updated by: Brett A Faine, University of Iowa

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

76

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All acute ischemic stroke patients who receive rtPA and transferred to our institution via our air ambulance service or present directly to our ED

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Intervention/Transfer
Patients who are transferred via air ambulance to a comprehensive stroke center
Drug: Tissue Plasminogen Activator
Control
Patients presenting directly to the comprehensive stroke center
Drug: Tissue Plasminogen Activator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Average Time to rtPA
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Iowa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

April 18, 2016

First Submitted That Met QC Criteria

April 22, 2016

First Posted (Estimate)

April 26, 2016

Study Record Updates

Last Update Posted (Actual)

July 5, 2019

Last Update Submitted That Met QC Criteria

June 28, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB:201507803

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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