Trial Outcomes & Findings for Thrombolytic Care During Inter-hospital Transfer (NCT NCT02752256)

NCT ID: NCT02752256

Last Updated: 2019-07-05

Results Overview

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

• Recruitment status: COMPLETED
• Target enrollment: 76 participants
• Primary outcome timeframe: 24 hours
• Results posted on: 2019-07-05

Participant Flow

Participant milestones

Measure	Intervention/Transfer Patients who are transferred via air ambulance to a comprehensive stroke center Tissue Plasminogen Activator	Control Patients presenting directly to the comprehensive stroke center Tissue Plasminogen Activator
Overall Study STARTED	35	41
Overall Study COMPLETED	35	41
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Thrombolytic Care During Inter-hospital Transfer

Baseline characteristics by cohort

Measure	Intervention/Transfer n=35 Participants Patients who are transferred via air ambulance to a comprehensive stroke center Tissue Plasminogen Activator	Control n=41 Participants Patients presenting directly to the comprehensive stroke center Tissue Plasminogen Activator	Total n=76 Participants Total of all reporting groups
Age, Continuous	67 years STANDARD_DEVIATION 14.3 • n=5 Participants	65 years STANDARD_DEVIATION 22.2 • n=7 Participants	66 years STANDARD_DEVIATION 18.7 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	20 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	21 Participants n=7 Participants	41 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	35 Participants n=5 Participants	41 Participants n=7 Participants	76 Participants n=5 Participants
Region of Enrollment United States	35 participants n=5 Participants	41 participants n=7 Participants	76 participants n=5 Participants
NIH Stroke Scale/Score (NIHSS)	8 units on a scale STANDARD_DEVIATION 8 • n=5 Participants	6 units on a scale STANDARD_DEVIATION 5 • n=7 Participants	7 units on a scale STANDARD_DEVIATION 6 • n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Intervention/Transfer n=35 Participants Patients who are transferred via air ambulance to a comprehensive stroke center Tissue Plasminogen Activator	Control n=41 Participants Patients presenting directly to the comprehensive stroke center Tissue Plasminogen Activator
Percentage of Participants With a rtPA Protocol Violation	7 Participants	0 Participants

SECONDARY outcome

Timeframe: 24 hours

Outcome measures

Measure	Intervention/Transfer n=35 Participants Patients who are transferred via air ambulance to a comprehensive stroke center Tissue Plasminogen Activator	Control n=41 Participants Patients presenting directly to the comprehensive stroke center Tissue Plasminogen Activator
Average Time to rtPA	74.5 Minutes Standard Deviation 34.2	60 Minutes Standard Deviation 31.2

Adverse Events

Intervention/Transfer

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Brett Faine

University of Iowa Hospitals and Clinics

Phone: 319-384-6800

Email: brett-faine@uiowa.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place