Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04951518
Other study ID # V-109
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 22, 2020
Est. completion date March 17, 2022

Study information

Verified date April 2022
Source Washington Regional Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

To investigate the reliability of VAN tool as administered by Emergency Medical Services personnel to predict presence of a large vessel occlusion in setting of cerebral ischemic infarction


Description:

The investigators propose to perform a 6-month pilot study in Northwest Arkansas in collaboration of two EMS providers; Central EMS and AirEvac. These local providers operate in the WRMC catchment area and transport over 90% of patients with a suspected stroke to WRMC comprehensive stroke center. Thus no changes to their standard operations would be implemented. The aim of this pilot study would be to test the accuracy of VAN-screening in the area in patients treated at WRMC - thus only patients who are brought to WRMC as per current protocol would be included in the study. The investigators would train Central EMS and AirEvac personnel to perform the V.A.N screen, over a 2-month period (estimated June-July 2020) in several sessions at the Central EMS training center at 800 S. School Ave. in Fayetteville. This training would be performed by study investigators, assisted by medical students, residents, and advanced practice nurses (APNs). The training would consist of a training video, hands-on instruction, and sample scenarios.The investigators would survey all training participants to gather feedback on the format, delivery, and understanding of the training material. The PowerPoint presentation planned for the training session, as well as the post-training quiz, are attached as Appendices to this application. The investigators would expect a rate of 80% correct answers in the post-training quiz. All questions and scenarios would be discussed with all trainees after the quiz, and re-takes would be allowed.


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date March 17, 2022
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Patients treated for stroke at WRMC who are transported to the hospital by Central EMS or AirEvac Exclusion Criteria: - Stroke patients who arrive directly to the hospital (without the use of EMS services)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
VAN Stroke Scale
V.A.N Stroke Assessment measures unilateral weakness with visual deficits, aphasia, and neglect in possible stroke patients

Locations

Country Name City State
United States Washington Regional Medical Center Fayetteville Arkansas

Sponsors (1)

Lead Sponsor Collaborator
Washington Regional Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reliability of VAN Assessment Tool To investigate the reliability of VAN tool as administered by Emergency Medical Services personnel to predict presence of a large vessel occlusion in setting of cerebral ischemic infarction 1 Year
Secondary Eligibility for Thrombolysis To investigate effect of the VAN tool to predict persons eligible for thrombolysis 1 Year
Secondary Eligibility for Thrombectomy To investigate effect of the VAN tool to predict persons eligible for thrombectomy 1 Year
Secondary Door to Intervention Time To investigate the effect of prehospital notification of VAN positive status vs routine notification on time door to needle or door to thrombectomy time 1 Year
Secondary Modified Rankin Score To compare the discharge disposition and Rankin score of patients post intervention with VAN prenotification vs routine notification. Rankin scores ranging from 0 - 5, with 0 being fully functioning and independent, and 5 being severe disability requiring constant nursing care. 1 Year
See also
  Status Clinical Trial Phase
Recruiting NCT06113848 - Adjunctive Use of Intra-Arterial TNK and Albumin Following Thrombectomy Phase 3
Completed NCT04069546 - The Efficacy of Remote Ischemic Conditioning on Stroke-induced Immunodeficiency N/A
Active, not recruiting NCT05700097 - Dengzhanxixin Injection for Acute Ischemic Stroke Receiving Reperfusion Therapy Phase 2
Recruiting NCT06058130 - Combination of Antiplatelet and Anticoagulation for AIS Patients Witn Concomitant NVAF and Extracranial/Intracranial Artery Stenosis N/A
Recruiting NCT04415164 - Evaluation of Xueshuantong in Patients With AcutE IschemiC STroke Phase 4
Recruiting NCT05363397 - Safety and Tolerability of Adjunctive TBO-309 in Reperfusion for Stroke Phase 2
Completed NCT05429658 - Single Arm Trial to Evaluate the Safety and Effectiveness of the Route 92 Medical Reperfusion System N/A
Recruiting NCT05390580 - Neuromodulation Using Vagus Nerve Stimulation Following Ischemic Stroke as Therapeutic Adjunct N/A
Enrolling by invitation NCT05515393 - A Study of XY03-EA Tablets in the Treatment of Acute Ischemic Stroke Phase 2
Active, not recruiting NCT05070260 - ACTISAVE: ACuTe Ischemic Stroke Study Evaluating Glenzocimab Used as Add-on Therapy Versus placEbo Phase 2/Phase 3
Terminated NCT05547412 - Validation of Velocity Curvature Index as a Diagnostic Biomarker Tool for Assessment of Large Vessel Stroke
Completed NCT03366818 - New Stent Retriever, VERSI System for AIS N/A
Not yet recruiting NCT06437431 - Glenzocimab in Anterior Stroke With Large Ischemic Core Eligible for Endovascular Therapy Phase 2/Phase 3
Not yet recruiting NCT05293080 - Early Treatment of Atrial Fibrillation for Stroke Prevention Trial in Acute STROKE Phase 3
Not yet recruiting NCT06040476 - Human Umbilical Cord Blood Infusion in Patients With Acute Ischemic Stroke (AIS) Phase 2
Completed NCT02223273 - Brazilian Intervention to Increase Evidence Usage in Practice - Stroke (BRIDGE-Stroke) N/A
Completed NCT02586233 - Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of DS-1040b in Subjects With Acute Ischemic Stroke Phase 1/Phase 2
Terminated NCT01694381 - Research Into the Effect of a Clot-dissolving Agent and Its Inhibitor Early Phase 1
Not yet recruiting NCT01594190 - Physical Activity Immediately After Acute Cerebral Ischemia N/A
Completed NCT01120301 - Efficacy and Safety Trial of Transcranial Laser Therapy Within 24 Hours From Stroke Onset (NEST-3) Phase 3