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

Acute Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05963685
• Other study ID #: MT-ALARM
• Status: Recruiting
• Start date: September 16, 2022
• Est. completion date: March 15, 2024

Study information

• Verified date: July 2023
• Source: Munich Municipal Hospital
• Contact: Hanni Wiestler, MD
• Phone: +49 89 6210 5895
• Email: hanni.wiestler[@]muenchen-klinik.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: March 15, 2024
• Est. primary completion date: March 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Ischemic Stroke
• Stroke

Intervention

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

Locations

Country	Name	City	State
Germany	Munich Municipal Hospital	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Munich Municipal Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	decision-to-arrival time	time from decision for MT to arrival of the patient at the primary thrombectomy center	24 hours
Secondary	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
Secondary	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
Secondary	decision-to-transfer request time	Time from decision for MT to request of emergency medical service for interhospital transfer	24 hours
Secondary	Periprocedural complications	rate of periprocedural complications during MT	24 hours
Secondary	Successful outcome of MT (mTICI > 2b)	rate of successfully performed MT (mTICI > 2b) of all patients with attempted MT	24 hours
Secondary	groin-to-recanalization time	Time from groin puncture to successful recanalization	24 hours
Secondary	Adverse events within 7 days	Adverse events within the first 7 days after transfer to referral center	7 days