Thrombolytic Care During Inter-hospital Transfer

NCT ID: NCT02752256

Last Updated: 2019-07-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

76 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Intervention/Transfer

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

Tissue Plasminogen Activator

Intervention Type DRUG

Control

Patients presenting directly to the comprehensive stroke center

Tissue Plasminogen Activator

Intervention Type DRUG

Interventions

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Tissue Plasminogen Activator

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Iowa

OTHER

Sponsor Role lead

Responsible Party

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Brett A Faine

Clinical Pharmacy Specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Site Status

Countries

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United States

References

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Faine BA, Dayal S, Kumar R, Lentz SR, Leira EC. Helicopter "Drip and Ship" Flights Do Not Alter the Pharmacological Integrity of rtPA. J Stroke Cerebrovasc Dis. 2018 Oct;27(10):2720-2724. doi: 10.1016/j.jstrokecerebrovasdis.2018.05.049. Epub 2018 Jul 20.

Reference Type DERIVED
PMID: 30037651 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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IRB:201507803

Identifier Type: -

Identifier Source: org_study_id

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