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

March 14, 2013 updated by: SITS International
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

3000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 17176
        • Recruiting
        • SITS International / Karolinska Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nils Wahlgren, Prof.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
January 2013-December 2014

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2014-2015

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SITS International

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

June 1, 2015

Study Completion (Anticipated)

June 1, 2015

Study Registration Dates

First Submitted

March 12, 2013

First Submitted That Met QC Criteria

March 14, 2013

First Posted (Estimate)

March 15, 2013

Study Record Updates

Last Update Posted (Estimate)

March 15, 2013

Last Update Submitted That Met QC Criteria

March 14, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20130214
  • 20130215

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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