Stroke
Conditions
Keywords
tissue plasminogen activator
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.
Interventions
Sponsors
University of Iowa
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a rtPA Protocol Violation | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Average Time to rtPA | 24 hours |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention/Transfer Patients who are transferred via air ambulance to a comprehensive stroke center
Tissue Plasminogen Activator | 35 |
| Control Patients presenting directly to the comprehensive stroke center
Tissue Plasminogen Activator | 41 |
| Total | 76 |
Baseline characteristics
| Characteristic | Intervention/Transfer | Control | Total |
|---|---|---|---|
| Age, Continuous | 67 years STANDARD_DEVIATION 14.3 | 65 years STANDARD_DEVIATION 22.2 | 66 years STANDARD_DEVIATION 18.7 |
| NIH Stroke Scale/Score (NIHSS) | 8 units on a scale STANDARD_DEVIATION 8 | 6 units on a scale STANDARD_DEVIATION 5 | 7 units on a scale STANDARD_DEVIATION 6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 35 Participants | 41 Participants | 76 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 35 participants | 41 participants | 76 participants |
| Sex: Female, Male Female | 15 Participants | 20 Participants | 35 Participants |
| Sex: Female, Male Male | 20 Participants | 21 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 35 | 1 / 41 |
| other Total, other adverse events | 0 / 35 | 0 / 41 |
| serious Total, serious adverse events | 0 / 35 | 0 / 41 |
Outcome results
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
Time frame: 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention/Transfer | Percentage of Participants With a rtPA Protocol Violation | 7 Participants |
| Control | Percentage of Participants With a rtPA Protocol Violation | 0 Participants |
Secondary
Average Time to rtPA
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention/Transfer | Average Time to rtPA | 74.5 Minutes | Standard Deviation 34.2 |
| Control | Average Time to rtPA | 60 Minutes | Standard Deviation 31.2 |