AzTrials
AzTrials

StrokePre-HASTNCT04555499

A Diagnosis Study of a New Prehospital Strokeidentification Test, the PreHospitalt Ambulans Stroke Test (PreHAST), to be Used to Triage Patients With Suspected Stroke

An observational study of Stroke, run by Karolinska Institutet at 2 sites in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The aim of the Pre-HAST study is to improve identification and triage of patients with suspected stroke in order to get the right patient to the right level of care as fast as possible. Furthermore, the scale is also intended to use follow stroke symptoms in emergency care. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke
What is being tested?
Standardized neurological examination
How many people
78 participants
Where
2 sitesSweden
Study dates
Jan 2014to Jan 2020
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: Patients with suspected stroke using pre hospital services in region Skåne, Sweden or being admited to Södersjukhuset in Stockholm, Sweden

Who may be able to join

  • Suspected stroke

Who cannot join

  • Unconscious

Trial locations and contacts

2 sites in 1 country.

Sweden2 sites
  • Pre hospital services in Skåne, Sweden

    Hässleholm, Skåne County

  • Södersjukhuset

    Stockholm

Other trials in Sweden

About this study

Official title: A Validation Study of a Structured Diagnostic Examination of Patients With Suspected or Confirmed Stroke Resulting in a Stroke Score

The aim of the Pre-HAST study is to improve identification and triage of patients with suspected stroke in order to get the right patient to the right level of care as fast as possible. Furthermore, the scale is also intended to use follow stroke symptoms in emergency care. The test is more extensive then the FAST or Cincinatti Stroke Scale and is in some aspects similar to the NIHSS but is shorter, easier and faster to perform to improve interexaminator variability and improve validity in less trained personal. The test is intended for awake patients with suspected stroke

Read the detailed description

PreHAST (PreHospital Ambulance Stroke Test)

  • for suspected stroke in awake patients The following parameters are tested.
  1. Commands • Evaluates ability to understand verbal commands (impressive aphasia?) and to carry out complex commands (apraxia?)
  • Give the command: open and close your eyes! Grip your hand! (non-paretic side) 0 - two correct 2 - one or none correct
  1. Eye position • Evaluates involuntary deviation of the gaze (déviation conjugée?). If present, this implies a serious injury and thus 2 p are given.
  • Observ if the patient have the eyes trained to one direction unmotivated 0 - normal 2 - Patient gaze in one direction only or preferably
  1. Visual field
  • The test should be conducte in both left and right visual field simulatneously to evaluate both if hemianopsia and/or negelct are present. Both symptoms implieas a sever injury and thus 2 p are given
  • Look the patient in the eyes and wave in both visual fields simultaneously. Ask the patient to point at the hand or hands waving. 0 - normal 2 - Only distinguishes one hand
  1. Facial palsy Ask the patient to smile 0 - normal 1 - one side of the mouth is hanging
  2. Arm paresis Is tested in lying or sitting position, one arm at the time. Start with the strongest arm. Lift the arm 45 degrees and ask the patient to keep in the position for 10 s. Count audible. If the patient can't lift the arm, assist. If the inability to keep the arm elevated is due to pain - score 0 Right Left 0 - can maintain the arm in postition for 10 s 1 - The arm drifts down from the initial position within 10 s but does not rely on support 2 - Falls down to support within 10 s or directly
  3. Leg paresis Test in lying or sitting position, one leg at the time. Start with the strongest leg. Lift the leg 30 degrees and ask the patient to keep in the position for 10 s. Count audible. If the patient can't lift the leg, assist. If the inability to keep the leg elevated is due to pain - score 0 Right Left 0 - can maintain the leg in position for 5 s 1 - The leg drifts down from the initial position within 5 s but does not rely on support 2 - Falls down to support within 5 s or directly
  4. Sensory (pain)
  • Evaluation of eventual loss of sensory function. It is important that pain is tested as not to miss a serious and not too uncommon type of stroke localized in the brain stem (Wallenberg´s syndrome).
  • Pinch the bend of the arms and legs, respectively. The stimuli shall be done simultaneously at the left and right side. Ask the patient if he/she can feel the stimuli in the same way on both sides. If the patient only registers stimuli on one side, 2 p are given. 0 - normal 1 - registers stimuli on both sides but less on one side 2 - Only registers the stimuli on one side
  1. Language • Evaluate if the patient has an understandable speech as stroke can cause both slurred speech (dysarthria) and affected ability to find words (aphasia). This test does not distinguish between dysarthria or dysphasia . Patient who does not speak at all (is mute) is given 2 p.
  • Ability to talk is noted during the examination. If uncertain, ask the patient to repeat: "the weather is pretty today" 0 - Normal 1 -Slight or moderate dysartria or aphasia. Communication possible. 2 - Severe dysarthria or aphasia. Communication basically not possible.
Conditions
Stroke
Being tested
Standardized neurological examination
Keywords
stroke pre hospital identification TIA, Patients with suspected stroke, Ability to give informed consent
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standardized neurological examinationOther

Study groups in NCT04555499
Study groupRoleWhat they receive
Suspected strokePatients with suspected stroke who are evaluated by paramedics
Receives: Other: Standardized neurological examination

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. stroke diagnosis

    The Pre-HAST is performed in the ambulance, in the emergency room or in the acute stroke ward. Final diagnosis of stroke and imaging data is matched to the findings in the Pre-HAST test

    Measured: within 2 weeks of recrutiment

Secondary outcomes (1)
  1. neuroimaging findings of large vessel oclusion

    Imaging findings of examined patients are reviewed

    Measured: within 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2020
  2. Study startJan 2014
  3. Primary completionMay 2014
  4. Study completionJan 2020

Resources

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
Case only
Time perspective
Prospective
Enrolment
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04555499
Sponsor's protocol ID
Pre-HAST
Acronym
Pre-HAST
Status last verified
Sep 2020
First submitted
9 Sep 2014
Last updated
18 Sep 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • Andsberg G, Esbjornsson M, Olofsson A, Lindgren A, Norrving B, von Euler M. PreHospital Ambulance Stroke Test - pilot study of a novel stroke test. Scand J Trauma Resusc Emerg Med. 2017 Apr 11;25(1):37. doi: 10.1186/s13049-017-0377-x.

    PubMed 28399897

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke, run by Karolinska Institutet at 2 sites in Sweden.

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 1 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: finished, as of the sponsor's last update on 18 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Sweden. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

stroke diagnosis (time frame: within 2 weeks of recrutiment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04555499, which also lists 1 linked publication.

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 18 Sep 2020.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in