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Reduction of In-hospital Delays in Stroke Thrombolysis: SITS-WATCH (SITS-WATCH)

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ClinicalTrials.gov Identifier: NCT01811901
Recruitment Status : Unknown
Verified March 2013 by SITS International.
Recruitment status was:  Recruiting
First Posted : March 15, 2013
Last Update Posted : March 15, 2013
Sponsor:
Information provided by (Responsible Party):
SITS International

Brief 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.

Condition or disease Intervention/treatment Phase
Stroke Other: Reduction of DTN Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Reduction of In-hospital Delays in Stroke Thrombolysis: SITS-WATCH
Study Start Date : January 2013
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Intervention group (SITS-WATCH centers)
15-item list of suggested interventions aiming to reduce DNT sent to SITS-WATCH centers.
Other: Reduction of DTN
15-item list of suggested interventions aiming to reduce DNT sent to SITS-WATCH centers.

No Intervention: Control group (non SITS-WATCH centers in SITS registry)
Centres that do not use 15-item list of suggested interventions aiming to reduce DNT.



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Significantly larger reduction of DNT in SITS-WATCH centers compared with non-SITS-WATCH centers in SITS. [ Time Frame: 2014-2015 ]
    Proportion of centers with median DNT below 40 minutes. At least 3 new interventions implemented. Percentage of implemented interventions.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All consecutive patients with acute ischemic stroke registered in SITS registry.

Exclusion Criteria:

  • Centers not inputing patient data into SITS registry. Patients with missing DNT data.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01811901


Contacts
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Contact: Nils Wahlgren, Prof. 0046 8 517 75 600 nils.wahlgren@karolinska.se
Contact: Daniel Strbian, Dr. Daniel.Strbian@hus.fi

Locations
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Sweden
SITS International / Karolinska Hospital Recruiting
Stockholm, Sweden, 17176
Contact: Nils Wahlgren, Prof.    0046851775606    nils.wahlgren@karolinska.se   
Contact: Oksana Petersen    0046765557885    oksana@sitsinternational.org   
Principal Investigator: Nils Wahlgren, Prof.         
Sponsors and Collaborators
SITS International

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Responsible Party: SITS International
ClinicalTrials.gov Identifier: NCT01811901     History of Changes
Other Study ID Numbers: 20130214
20130215
First Posted: March 15, 2013    Key Record Dates
Last Update Posted: March 15, 2013
Last Verified: March 2013
Keywords provided by SITS International:
inhospital delays, door-to-needle time, thrombolysis, acute ischemic stroke, SITS, SITS-WATCH, stroke registry
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases