NCT05963685

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
280

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 16, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 27, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2024

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

1.5 years

First QC Date

July 19, 2023

Last Update Submit

July 19, 2023

Conditions

Keywords

mechanical thrombectomy, telestroke, drip and ship, interhospital transfer, communication

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • decision-to-departure time

    24 hours

  • decision-to-arrival time

    24 hours

  • arrival-to-groin time

    24 hours

  • rate of refusal of transfer requests due to lack of capacity

    24 hours

  • decision-to-transfer request time

    24 hours

  • +4 more secondary outcomes

Study Arms (3)

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

post implementation period

stroke patients transferred within the 6-12 months after introduction of the alarming system

Other: standardized MT alarming system

Interventions

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

implementation periodpost implementation period

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Munich Municipal Hospital

Munich, Bavaria, 81545, Germany

RECRUITING

MeSH Terms

Conditions

Ischemic StrokeCommunication

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBehavior

Central Study Contacts

Nikolai Hubert

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2023

First Posted

July 27, 2023

Study Start

September 16, 2022

Primary Completion

March 15, 2024

Study Completion

March 15, 2024

Last Updated

July 27, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

No plan to make IPD available to other researchers.

Locations