NCT02752256

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 26, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

July 5, 2019

Completed
Last Updated

July 5, 2019

Status Verified

June 1, 2019

Enrollment Period

2 years

First QC Date

April 18, 2016

Results QC Date

January 11, 2019

Last Update Submit

June 28, 2019

Conditions

Keywords

tissue plasminogen activator

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Average Time to rtPA

    24 hours

Study Arms (2)

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

Interventions

ControlIntervention/Transfer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Patients who received tissue plasminogen activator for acute ischemic stroke
  • presented directly to comprehensive stroke center or were transferred by our air ambulance service

You may not qualify if:

  • Transferred by another air ambulance service or ground ambulance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Stroke

Interventions

Tissue Plasminogen Activator

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Serine EndopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesSerine ProteasesPlasminogen ActivatorsBlood Coagulation FactorsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsBiological Factors

Results Point of Contact

Title
Brett Faine
Organization
University of Iowa Hospitals and Clinics

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Pharmacy Specialist

Study Record Dates

First Submitted

April 18, 2016

First Posted

April 26, 2016

Study Start

October 1, 2015

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

July 5, 2019

Results First Posted

July 5, 2019

Record last verified: 2019-06

Locations