Acute Ischemic StrokeNCT05963685
Impact of a Standardized Alarming System on Treatment Times and Workflow in Stroke Patients With Interhospital Transfer for Thrombectomy
An observational study of Acute Ischemic Stroke, run by Munich Municipal Hospital at 1 site in Germany.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- standardized MT alarming system
- How many people
- 280 participants
- Where
- 1 siteGermany
- Study dates
- 16 Sep 2022to 15 Mar 2024
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- unclear indication for mechanical thrombectomy (patients admitted for perfusion imaging before decision for or against a MT)
Trial locations and contacts
1 site in 1 country.
Nikolai Hubert contact
Germany1 site, 1 recruiting
- Recruiting
Munich Municipal Hospital
Munich, Bavaria, 81545
Nikolai Hubert, MSc, +49 89 6210 3325, nikolai.hubert@muenchen-klinik.de
Hanni Wiestler, MD, +49 89 6210 5895, hanni.wiestler@muenchen-klinik.de
About this study
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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- standardized MT alarming system
- Keywords
- mechanical thrombectomy, telestroke, drip and ship, interhospital transfer, communication
- Medical subject headings
- Ischemic Stroke, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standardized MT alarming systemOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: standardized MT alarming system | |
| post implementation period | stroke patients transferred within the 6-12 months after introduction of the alarming system Receives: Other: standardized MT alarming system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 24 hours
Secondary outcomes (9)
decision-to-departure time
time from decision for MT to departure of the patient from primary stroke center (to the primary thrombectomy center)
Measured: 24 hours
decision-to-arrival time
time from decision for MT to arrival of the patient at the primary thrombectomy center
Measured: 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)
Measured: 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
Measured: 24 hours
decision-to-transfer request time
Time from decision for MT to request of emergency medical service for interhospital transfer
Measured: 24 hours
Periprocedural complications
rate of periprocedural complications during MT
Measured: 24 hours
Successful outcome of MT (mTICI > 2b)
rate of successfully performed MT (mTICI > 2b) of all patients with attempted MT
Measured: 24 hours
groin-to-recanalization time
Time from groin puncture to successful recanalization
Measured: 24 hours
Adverse events within 7 days
Adverse events within the first 7 days after transfer to referral center
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start16 Sep 2022
- Primary completion15 Mar 2024 (estimated)
- Study completion15 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 280 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Munich Municipal Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05963685
- Sponsor's protocol ID
- MT-ALARM
- Status last verified
- Jul 2023
- First submitted
- 19 Jul 2023
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to make IPD available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Standardized Alarming System on Treatment Times and Workflow in Stroke Patients With Interhospital Transfer for Thrombectomy
- ClinicalTrials.gov ID
- NCT05963685
- Acronym / sponsor ID
- MT-ALARM
- Conditions
- Acute Ischemic Stroke
- Keywords
- mechanical thrombectomy, telestroke, drip and ship, interhospital transfer, communication
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Munich Municipal HospitalUniversity, hospital or other
- Study start
- 16 Sep 2022 (actual)
- Primary completion
- 15 Mar 2024 (estimated)
- Study completion
- 15 Mar 2024 (estimated)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| pre implementation period | – | –stroke patients transferred within the 6 months before introduction of the alarming system |
| implementation period | – | Other: standardized MT alarming systemstroke patients transferred within the 6 months after introduction of the alarming system |
| post implementation period | – | Other: standardized MT alarming systemstroke patients transferred within the 6-12 months after introduction of the alarming system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- unclear indication for mechanical thrombectomy (patients admitted for perfusion imaging before decision for or against a MT)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standardized MT alarming systemStandardized 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 | Other | implementation period, post implementation period |
Primary outcome
decision-to-groin time
Time frame: 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)
9 secondary outcomes
decision-to-departure time
Time frame: 24 hours
decision-to-arrival time
Time frame: 24 hours
arrival-to-groin time
Time frame: 24 hours
rate of refusal of transfer requests due to lack of capacity
Time frame: 24 hours
decision-to-transfer request time
Time frame: 24 hours
Periprocedural complications
Time frame: 24 hours
Successful outcome of MT (mTICI > 2b)
Time frame: 24 hours
groin-to-recanalization time
Time frame: 24 hours
Adverse events within 7 days
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Individual participant dataSharing planned: No. No plan to make IPD available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nikolai Hubert contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischemic Stroke, run by Munich Municipal Hospital at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hanni Wiestler, MD (+49 89 6210 5895, hanni.wiestler@muenchen-klinik.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
decision-to-groin time (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.