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

Recruiting

• Conditions: Acute Ischemic Stroke
• Interventions: Other: standardized MT alarming system

• Registration Number: NCT05963685
• Lead Sponsor: Munich Municipal Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-16
• Status Verified: 2023-07
• Study First Submitted: 2023-07-19
• Study First Submitted QC: 2023-07-19
• Last Update Submitted: 2023-07-19
• Study First Posted: 2023-07-27
• Last Update Posted: 2023-07-27
• Primary Completion: 2024-03-15
• Study Completion: 2024-03-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 280

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
implementation period	standardized MT alarming system	stroke patients transferred within the 6 months after introduction of the alarming system
post implementation period	standardized MT alarming system	stroke patients transferred within the 6-12 months after introduction of the alarming system

Primary Outcome Measures

Name	Time	Method
decision-to-groin time	24 hours	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)

Secondary Outcome Measures

Name	Time	Method
decision-to-transfer request time	24 hours	Time from decision for MT to request of emergency medical service for interhospital transfer
Successful outcome of MT (mTICI > 2b)	24 hours	rate of successfully performed MT (mTICI \> 2b) of all patients with attempted MT
decision-to-departure time	24 hours	time from decision for MT to departure of the patient from primary stroke center (to the primary thrombectomy center)
rate of refusal of transfer requests due to lack of capacity	24 hours	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
Adverse events within 7 days	7 days	Adverse events within the first 7 days after transfer to referral center
decision-to-arrival time	24 hours	time from decision for MT to arrival of the patient at the primary thrombectomy center
groin-to-recanalization time	24 hours	Time from groin puncture to successful recanalization
arrival-to-groin time	24 hours	time from arrival of the patient at the primary thrombectomy center to groin puncture (start of mechanical thrombectomy procedure)
Periprocedural complications	24 hours	rate of periprocedural complications during MT

Trial Locations

Locations (1)

Munich Municipal Hospital; 🇩🇪 Munich, Bavaria, Germany