Impact of a Standardized Alarming System on Treatment Times and Workflow in Stroke Patients With Interhospital Transfer for Thrombectomy

The aim of this study is to evaluate the impact of a standardized alarming system on treatment times and workflow in stroke patients with interhospital transfer for mechanical thrombectomy (MT). The main questions it aims to answer are:

• Is the implementation of a standardized alarming system associated with shorter transfer and treatment times?
• Is the implementation of a standardized alarming system associated with a better adherence on existing standard operating procedures for interhospital transfer? We will analyze data from our existing thrombectomy registry comparing time periods before and after introduction of the MT alarming system.

Study Overview

• Status: Recruiting
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Other: standardized MT alarming system

• Study Type: Observational
• Enrollment (Estimated): 280

Contacts and Locations

• Study Contact: Name: Hanni Wiestler, MD; Phone Number: +49 89 6210 5895; Email: hanni.wiestler@muenchen-klinik.de
• Study Contact Backup: Name: Nikolai Hubert; Phone Number: +49 89 6210 3325

Study Locations

• Germany
  • Bavaria
    • Munich, Bavaria, Germany, 81545
      • Recruiting
      • Munich Municipal Hospital
      • Contact: Hanni Wiestler, MD; Phone Number: +49 89 6210 5895; Email: hanni.wiestler@muenchen-klinik.de
      • Contact: Nikolai Hubert, MSc; Phone Number: +49 89 6210 3325; Email: nikolai.hubert@muenchen-klinik.de
      • Principal Investigator: Hanni Wiestler, MD
      • Principal Investigator: Nikolai Hubert, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Acute ischemic stroke patients admitted to one of 7 nonurban primary stroke centers with subsequent interhospital transfer to a referral center for mechanical thrombectomy in Southeast Bavaria, Germany.

Description

Inclusion Criteria:

• age >= 18 years
• diagnosis of acute ischemic stroke
• indication for mechanical thrombectomy
• admission to one of 7 participating primary stroke centers within in the catchment area of the referral center

Exclusion Criteria:

• unclear indication for mechanical thrombectomy (patients admitted for perfusion imaging before decision for or against a MT)

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
pre implementation period; stroke patients transferred within the 6 months before introduction of the alarming system
implementation period; stroke patients transferred within the 6 months after introduction of the alarming system	Other: standardized MT alarming system; Standardized alarming system via telephone loop in the primary thrombectomy centre triggered immediately after decision to mechanical thrombectomy in stroke patients admitted in primary stroke centers
post implementation period; stroke patients transferred within the 6-12 months after introduction of the alarming system	Other: standardized MT alarming system; Standardized alarming system via telephone loop in the primary thrombectomy centre triggered immediately after decision to mechanical thrombectomy in stroke patients admitted in primary stroke centers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
decision-to-groin time	time from decision for MT (while patient still in the primary stroke center) to groin puncture (start of mechanical thrombectomy procedure in the primary thrombectomy center)	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
decision-to-departure time	time from decision for MT to departure of the patient from primary stroke center (to the primary thrombectomy center)	24 hours
decision-to-arrival time	time from decision for MT to arrival of the patient at the primary thrombectomy center	24 hours
arrival-to-groin time	time from arrival of the patient at the primary thrombectomy center to groin puncture (start of mechanical thrombectomy procedure)	24 hours
rate of refusal of transfer requests due to lack of capacity	rate of patients that had to be transferred to a secondary thrombectomy center instead of the primary thrombectomy centre due to lack of capacity in the referral clinic	24 hours
decision-to-transfer request time	Time from decision for MT to request of emergency medical service for interhospital transfer	24 hours
Periprocedural complications	rate of periprocedural complications during MT	24 hours
Successful outcome of MT (mTICI > 2b)	rate of successfully performed MT (mTICI > 2b) of all patients with attempted MT	24 hours
groin-to-recanalization time	Time from groin puncture to successful recanalization	24 hours
Adverse events within 7 days	Adverse events within the first 7 days after transfer to referral center	7 days

Collaborators and Investigators

• Sponsor: Munich Municipal Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2022
• Primary Completion (Estimated): March 15, 2024
• Study Completion (Estimated): March 15, 2024

Study Registration Dates

• First Submitted: July 19, 2023
• First Submitted That Met QC Criteria: July 19, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 19, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: mechanical thrombectomy, telestroke, drip and ship, interhospital transfer, communication
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: MT-ALARM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to make IPD available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No