Viewing Study NCT02752256


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Study NCT ID: NCT02752256
Status: COMPLETED
Last Update Posted: 2019-07-05
First Post: 2016-04-18
Is NOT Gene Therapy: False
Has Adverse Events: True

Brief Title: Thrombolytic Care During Inter-hospital Transfer
Sponsor: University of Iowa
Organization:

Study Overview

Official Title: Quality and Effectiveness of Thrombolytic Care During Inter-hospital Transfer ("Drip-Ship") With Air Ambulance Services
Status: COMPLETED
Status Verified Date: 2019-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: