Thrombolytic Care During Inter-hospital Transfer

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02752256
• Other study ID #: IRB:201507803
• Status: Completed
• Start date: October 2015
• Est. completion date: October 2017

Study information

• Verified date: June 2019
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Drug:
• Tissue Plasminogen Activator

Locations

Country	Name	City	State
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
University of Iowa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With a rtPA Protocol Violation	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	Average Time to rtPA		24 hours