to reduce the time between sounding alarm by the patient and start of intravenous thrombolysis and/ or intra-arterial trombectomy in patients with acute ischemic stroke. In a side-line study we will elucidate factors that contributed to a delay in…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
TSD to IAT and TSD to IVT.
Secondary outcome
- the proportion of patients finally treated with IVT /IAT calculated from:
- the total of patients for whom the ambulance issues a dispatch
- the total of patients transferred to the hospital with suspected stroke
- the total of patients with a final diagnosis of (ischemic) stroke
- functional outcome at three-months measured by telephone with the modified
Rankin scale
Background summary
For the clinical benefit of intravenous thrombolysis (IVT) or intra-arterial
trombectomy (IAT) time is the most crucial factor (time=brain). Reducing the
time between stroke onset en treatment is therefore a major goal. The delay
from first sounding alarm and the start of treatment with IVT/IAT aslo called
the *total system delay* (TSD) dependents very much on logistics and how
various caregivers in this trajectory work together. A promising method to
reduce the TSD is direct visual feedback to caregivers involved with the
patient to encourage them to work more efficiently. In order to investigate
this, however, it is important to have an accurate registration of the TSD,
which is currently lacking.
Study objective
to reduce the time between sounding alarm by the patient and start of
intravenous thrombolysis and/ or intra-arterial trombectomy in patients with
acute ischemic stroke. In a side-line study we will elucidate factors that
contributed to a delay in calling for help by the patient or bystanders.
Study design
First we will set up an electronic and automated way of tracking the TSD. Next
we will start a multiregional, multicentre prospective randomized open
end-point trial to investigate if direct visual feedback to caregivers reduces
the TSD.
Intervention
The intervention is not aimed at the patient but at the caregivers involved in
acute stroke: direct visual feedback on the actual treatement delays for the
patient they are transferring for IVT/IAT
Study burden and risks
We expect no buren or risk for the patient. The tracking device is already in
use at the cardiology department of the Leiden University Medical Centre.
Patients have never complaint of any inconvenience so far. The wristband they
recieve up till IVT/IAT has been administred is comparable with the patient
identifying wristband they receive. A formal risk assessment did not show any
interference with existing medical equipment.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
All patients with suspected stroke potentially eligible for IVT and/or IAT for whom the dispatch office send out an ambulance.
Exclusion criteria
younger than 18 years
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
ClinicalTrials.gov | NCT02808806 |
CCMO | NL56747.058.16 |