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Evaluation of ischemic stroke patients receiving tissue plasminogen activator (rtPA) during air ambulance transfer
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention/Transfer | Patients who are transferred via air ambulance to a comprehensive stroke center |
| |
| Control | Patients presenting directly to the comprehensive stroke center |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tissue Plasminogen Activator | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Average Time to rtPA | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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All acute ischemic stroke patients who receive rtPA and transferred to our institution via our air ambulance service or present directly to our ED
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30037651 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention/Transfer | Patients who are transferred via air ambulance to a comprehensive stroke center Tissue Plasminogen Activator |
| FG001 | Control | Patients presenting directly to the comprehensive stroke center Tissue Plasminogen Activator |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention/Transfer | Patients who are transferred via air ambulance to a comprehensive stroke center Tissue Plasminogen Activator |
| BG001 | Control | Patients presenting directly to the comprehensive stroke center Tissue Plasminogen Activator |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | 24 hours |
|
In-hospital mortality, serious adverse events, adverse events up to 90 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention/Transfer | Patients who are transferred via air ambulance to a comprehensive stroke center Tissue Plasminogen Activator |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brett Faine | University of Iowa Hospitals and Clinics | 319-384-6800 | brett-faine@uiowa.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 11, 2015 | Apr 11, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D010959 | Tissue Plasminogen Activator |
| ID | Term |
|---|---|
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
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| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| NIH Stroke Scale/Score (NIHSS) | Minimum 0 (good clinical outcome), Maximum 42 (poor clinical outcome) | Mean | Standard Deviation | units on a scale |
|
|
|
| Secondary | Average Time to rtPA | Posted | Mean | Standard Deviation | Minutes | 24 hours |
|
|
|
| 2 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | Control | Patients presenting directly to the comprehensive stroke center Tissue Plasminogen Activator | 1 | 41 | 0 | 41 | 0 | 41 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D010960 | Plasminogen Activators |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001685 | Biological Factors |