StrokeSITS-WATCHNCT01811901
Reduction of In-hospital Delays in Stroke Thrombolysis: SITS-WATCH
A study testing Reduction of DTN in people with Stroke, run by SITS International at 1 site in Sweden.
Trial summary
In patients with acute ischemic stroke: the sooner the thrombolysis treatment is administered after symptom onset - the better the outcome. This delay can be dissected into onset-to-door time and door-to-needle time (DNT). SITS-WATCH aims to reduce median DNT in participating centres. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Reduction of DTN
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2013to Jun 2015
- Phase
- Interventional
- 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
Who may be able to join
- All consecutive patients with acute ischemic stroke registered in SITS registry.
Who cannot join
- Centers not inputing patient data into SITS registry. Patients with missing DNT data.
Trial locations and contacts
1 site in 1 country.
Daniel Strbian, Dr. contact
Sweden1 site, 1 recruiting
- Recruiting
SITS International / Karolinska Hospital
Stockholm, 17176
Nils Wahlgren, Prof., 0046851775606, nils.wahlgren@karolinska.se
Oksana Petersen, 0046765557885, oksana@sitsinternational.org
About this study
In patients with acute ischemic stroke: the sooner the thrombolysis treatment is administered after symptom onset - the better the outcome. This delay can be dissected into onset-to-door time and door-to-needle time (DNT). SITS-WATCH aims to reduce median DNT in participating centres.
Read the detailed description
In patients with acute ischemic stroke: the sooner the thrombolysis treatment is administered after symptom onset - the better the outcome. This delay can be dissected into onset-to-door time and door-to-needle time (DNT). Of the two, DNT can be directly influenced within the hospital by stream-lining of acute stroke care. The aim of our study is to reduce in-hospital delays (DNT) in self-selecting centers recruiting patients into the the Safe Implementation of Treatments in Stroke-International Stroke Thrombolysis Register (SITS-ISTR) , comprising currently more than 80 000 patients from 1338 centers. Current median of DNT in all SITS centers is 65 minutes (compared with 20 minutes in Helsinki Univer-sity Central Hospital). An itemized detailed questionnaire, including all factors known to influence DNT, has been sent to all SITS centers to identify the reasons for long in-hospital delays. Based on the replies, we have prepared a list of interventions that can be considered by individual SITS centers in order to reduce DNT with interventions that are in line with national legislation.
- Conditions
- Stroke
- Being tested
- Reduction of DTN
- Keywords
- inhospital delays, door-to-needle time, thrombolysis, acute ischemic stroke, SITS, SITS-WATCH, stroke registry
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduction of DTNOther
15-item list of suggested interventions aiming to reduce DNT sent to SITS-WATCH centers.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group (SITS-WATCH centers) | Active comparator | 15-item list of suggested interventions aiming to reduce DNT sent to SITS-WATCH centers. Receives: Other: Reduction of DTN |
| Control group (non SITS-WATCH centers in SITS registry) | No intervention | Centres that do not use 15-item list of suggested interventions aiming to reduce DNT. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute DNT reduction of at least 20 minutes or at least 20% change in SITS-WATCH centers that completed the whole study period
DNT will be evaluated at regular intervals (twice a year).
Measured: January 2013-December 2014
Secondary outcomes (1)
Significantly larger reduction of DNT in SITS-WATCH centers compared with non-SITS-WATCH centers in SITS.
Proportion of centers with median DNT below 40 minutes. At least 3 new interventions implemented. Percentage of implemented interventions.
Measured: 2014-2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2013 (estimated)
- Study startJan 2013
- Primary completionJun 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SITS International
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01811901
- Sponsor's protocol ID
- 20130214
- Other IDs
- 20130215
- Acronym
- SITS-WATCH
- Status last verified
- Mar 2013
- First submitted
- 12 Mar 2013
- Last updated
- 15 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of In-hospital Delays in Stroke Thrombolysis: SITS-WATCH
- ClinicalTrials.gov ID
- NCT01811901
- Acronym / sponsor ID
- SITS-WATCH / 20130214
- Conditions
- Stroke
- Keywords
- inhospital delays, door-to-needle time, thrombolysis, acute ischemic stroke, SITS, SITS-WATCH, stroke registry
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- SITS InternationalResearch network
- Study start
- Jan 2013
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 15 Mar 2013 (estimated)
- 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.
In patients with acute ischemic stroke: the sooner the thrombolysis treatment is administered after symptom onset - the better the outcome. This delay can be dissected into onset-to-door time and door-to-needle time (DNT). SITS-WATCH aims to reduce median DNT in participating centres.
Detailed description
In patients with acute ischemic stroke: the sooner the thrombolysis treatment is administered after symptom onset - the better the outcome. This delay can be dissected into onset-to-door time and door-to-needle time (DNT). Of the two, DNT can be directly influenced within the hospital by stream-lining of acute stroke care. The aim of our study is to reduce in-hospital delays (DNT) in self-selecting centers recruiting patients into the the Safe Implementation of Treatments in Stroke-International Stroke Thrombolysis Register (SITS-ISTR) , comprising currently more than 80 000 patients from 1338 centers. Current median of DNT in all SITS centers is 65 minutes (compared with 20 minutes in Helsinki Univer-sity Central Hospital). An itemized detailed questionnaire, including all factors known to influence DNT, has been sent to all SITS centers to identify the reasons for long in-hospital delays. Based on the replies, we have prepared a list of interventions that can be considered by individual SITS centers in order to reduce DNT with interventions that are in line with national legislation.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group (SITS-WATCH centers) | Active comparator | Other: Reduction of DTN15-item list of suggested interventions aiming to reduce DNT sent to SITS-WATCH centers. |
| Control group (non SITS-WATCH centers in SITS registry) | No intervention | –Centres that do not use 15-item list of suggested interventions aiming to reduce DNT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All consecutive patients with acute ischemic stroke registered in SITS registry.
Key exclusion criteria (1 listed)
- Centers not inputing patient data into SITS registry. Patients with missing DNT data.
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 |
|---|---|---|
| Reduction of DTN15-item list of suggested interventions aiming to reduce DNT sent to SITS-WATCH centers. | Other | Intervention group (SITS-WATCH centers) |
Primary outcome
Absolute DNT reduction of at least 20 minutes or at least 20% change in SITS-WATCH centers that completed the whole study period
Time frame: January 2013-December 2014
DNT will be evaluated at regular intervals (twice a year).
1 secondary outcome
Significantly larger reduction of DNT in SITS-WATCH centers compared with non-SITS-WATCH centers in SITS.
Time frame: 2014-2015
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2013.
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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.
Daniel Strbian, Dr. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reduction of DTN in people with Stroke, run by SITS International at 1 site 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: status not confirmed, as of the sponsor's last update on 15 Mar 2013. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nils Wahlgren, Prof. (0046 8 517 75 600, nils.wahlgren@karolinska.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute DNT reduction of at least 20 minutes or at least 20% change in SITS-WATCH centers that completed the whole study period (time frame: January 2013-December 2014). 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 15 Mar 2013.