Thrombolytic Care During Inter-hospital Transfer

Completed

• Conditions: Stroke
• Interventions: Drug: Tissue Plasminogen Activator

• Registration Number: NCT02752256
• Lead Sponsor: University of Iowa

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 Timeline

• Study Start: 2015-10
• Study First Submitted: 2016-04-18
• Study First Submitted QC: 2016-04-22
• Study First Posted: 2016-04-26
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Results First Submitted: 2019-01-11
• Status Verified: 2019-06
• Results First Submitted QC: 2019-06-28
• Last Update Submitted: 2019-06-28
• Results First Posted: 2019-07-05
• Last Update Posted: 2019-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With a rtPA Protocol Violation	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 Outcome Measures

Name	Time	Method
Average Time to rtPA	24 hours

Trial Locations

Locations (1)

University of Iowa Hospitals and Clinics; 🇺🇸 Iowa City, Iowa, United States