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

Primary Purpose

Stroke

Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Reduction of DTN
Sponsored by
SITS International
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Stroke focused on measuring inhospital delays, door-to-needle time, thrombolysis, acute ischemic stroke, SITS, SITS-WATCH, stroke registry

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • SITS International / Karolinska HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intervention group (SITS-WATCH centers)

Control group (non SITS-WATCH centers in SITS registry)

Arm Description

15-item list of suggested interventions aiming to reduce DNT sent to SITS-WATCH centers.

Centres that do not use 15-item list of suggested interventions aiming to reduce DNT.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

Full Information

First Posted
March 12, 2013
Last Updated
March 14, 2013
Sponsor
SITS International
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1. Study Identification

Unique Protocol Identification Number
NCT01811901
Brief Title
Reduction of In-hospital Delays in Stroke Thrombolysis: SITS-WATCH
Acronym
SITS-WATCH
Official Title
Reduction of In-hospital Delays in Stroke Thrombolysis: SITS-WATCH
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
June 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SITS International

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
inhospital delays, door-to-needle time, thrombolysis, acute ischemic stroke, SITS, SITS-WATCH, stroke registry

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
3000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group (SITS-WATCH centers)
Arm Type
Active Comparator
Arm Description
15-item list of suggested interventions aiming to reduce DNT sent to SITS-WATCH centers.
Arm Title
Control group (non SITS-WATCH centers in SITS registry)
Arm Type
No Intervention
Arm Description
Centres that do not use 15-item list of suggested interventions aiming to reduce DNT.
Intervention Type
Other
Intervention Name(s)
Reduction of DTN
Intervention Description
15-item list of suggested interventions aiming to reduce DNT sent to SITS-WATCH centers.
Primary Outcome Measure Information:
Title
Absolute DNT reduction of at least 20 minutes or at least 20% change in SITS-WATCH centers that completed the whole study period
Description
DNT will be evaluated at regular intervals (twice a year).
Time Frame
January 2013-December 2014
Secondary Outcome Measure Information:
Title
Significantly larger reduction of DNT in SITS-WATCH centers compared with non-SITS-WATCH centers in SITS.
Description
Proportion of centers with median DNT below 40 minutes. At least 3 new interventions implemented. Percentage of implemented interventions.
Time Frame
2014-2015

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nils Wahlgren, Prof.
Phone
0046 8 517 75 600
Email
nils.wahlgren@karolinska.se
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Strbian, Dr.
Email
Daniel.Strbian@hus.fi
Facility Information:
Facility Name
SITS International / Karolinska Hospital
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nils Wahlgren, Prof.
Phone
0046851775606
Email
nils.wahlgren@karolinska.se
First Name & Middle Initial & Last Name & Degree
Oksana Petersen
Phone
0046765557885
Email
oksana@sitsinternational.org
First Name & Middle Initial & Last Name & Degree
Nils Wahlgren, Prof.

12. IPD Sharing Statement

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

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