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

Stroke Clinical Trial

— SITS-WATCH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01811901
• Other study ID #: 20130214
• Secondary ID: 20130215
• Status: Recruiting
• Phase: N/A
• First received: March 12, 2013
• Last updated: March 14, 2013
• Start date: January 2013
• Est. completion date: June 2015

Study information

• Verified date: March 2013
• Source: SITS International
• Contact: Nils Wahlgren, Prof.
• Phone: 0046 8 517 75 600
• Email: nils.wahlgren[@]karolinska.se
• Is FDA regulated: No
• Health authority: Sweden: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Reduction of DTN
15-item list of suggested interventions aiming to reduce DNT sent to SITS-WATCH centers.

Locations

Country	Name	City	State
Sweden	SITS International / Karolinska Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
SITS International

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	January 2013-December 2014	Yes
Secondary	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.	2014-2015	Yes