StrokeNCT02752256

Thrombolytic Care During Inter-hospital Transfer

An observational study of Stroke, run by University of Iowa at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Evaluation of ischemic stroke patients receiving tissue plasminogen activator (rtPA) during air ambulance transfer Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Stroke
What is being tested?: Tissue Plasminogen Activator
How many people: 76 participants
Where: 1 siteUnited States
Study dates: Oct 2015to Oct 2017
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

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

Who may be able to join

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

Who cannot join

Transferred by another air ambulance service or ground ambulance

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242

Other trials in United States

About this study

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

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

Read the 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.

Conditions: Stroke
Being tested: Tissue Plasminogen Activator
Keywords: tissue plasminogen activator
Medical subject headings: Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tissue Plasminogen ActivatorDrug

Study groups in NCT02752256
Study group	Role	What they receive
Intervention/Transfer		Patients who are transferred via air ambulance to a comprehensive stroke center Receives: Drug: Tissue Plasminogen Activator
Control		Patients presenting directly to the comprehensive stroke center Receives: Drug: Tissue Plasminogen Activator

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 24 hours

Secondary outcomes (1)

Average Time to rtPA
Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2015Oct 2017

First posted26 Apr 2016 (estimated)
Study startOct 2015
Primary completionOct 2017
Study completionOct 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for StrokeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 76 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02752256
Sponsor's protocol ID: IRB:201507803
Status last verified: Jun 2019
First submitted: 18 Apr 2016
Last updated: 5 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 30037651

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
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A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
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CoMind Early Feasibility Study
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All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Quality and Effectiveness of Thrombolytic Care During Inter-hospital Transfer ("Drip-Ship") With Air Ambulance Services
ClinicalTrials.gov ID: NCT02752256
Acronym / sponsor ID: IRB:201507803
Conditions: Stroke
Keywords: tissue plasminogen activator
Study type: Observational
Recruitment status: Completed
Enrolment: 76 participants (actual)
Lead sponsor: University of IowaUniversity, hospital or other
Study start: Oct 2015
Primary completion: Oct 2017 (actual)
Study completion: Oct 2017 (actual)
First posted: 26 Apr 2016 (estimated)
Results: Posted 5 Jul 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Intervention/Transfer	–	Drug: Tissue Plasminogen ActivatorPatients who are transferred via air ambulance to a comprehensive stroke center
Control	–	Drug: Tissue Plasminogen ActivatorPatients presenting directly to the comprehensive stroke center

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
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

Key inclusion criteria (2 listed)

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

Key exclusion criteria (1 listed)

Transferred by another air ambulance service or ground ambulance

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Tissue Plasminogen Activator	Drug	Control, Intervention/Transfer

Primary outcome

Percentage of Participants With a rtPA Protocol Violation
Time frame: 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

1 secondary outcome

Average Time to rtPA
Time frame: 24 hours

Results and safety

Results posted to the registry on 5 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention/Transfer	35	35
Control	41	41

Primary outcome: Percentage of Participants With a rtPA Protocol Violation

Time frame: 24 hours. Count of participants. Unit: Participants

Measure	Intervention/Transfer n = 35	Control n = 41
Value	7	0

1 secondary outcome is reported in the full results.

Adverse events

Time frame: In-hospital mortality, serious adverse events, adverse events up to 90 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention/Transfer	0 of 35 (0%)	0 of 35 (0%)	2 of 35
Control	0 of 41 (0%)	0 of 41 (0%)	1 of 41

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30037651Faine 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.

Related trials for Stroke

Recruiting
Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
Ischemic Stroke
RecruitingObservational study
Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage, Stroke
Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke, run by University of Iowa at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With a rtPA Protocol Violation (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02752256, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.