NCT01811901

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 15, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

March 15, 2013

Status Verified

March 1, 2013

Enrollment Period

2.4 years

First QC Date

March 12, 2013

Last Update Submit

March 14, 2013

Conditions

Stroke

Keywords

inhospital delays, door-to-needle time, thrombolysis, acute ischemic stroke, SITS, SITS-WATCH, stroke registry

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Significantly larger reduction of DNT in SITS-WATCH centers compared with non-SITS-WATCH centers in SITS.

    2014-2015

Study Arms (2)

Intervention group (SITS-WATCH centers)

ACTIVE COMPARATOR

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

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.

Interventions

Reduction of DTNOTHER

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

Intervention group (SITS-WATCH centers)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SITS International / Karolinska Hospital

Stockholm, 17176, Sweden

RECRUITING

MeSH Terms

Conditions

StrokeIschemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Nils Wahlgren, Prof.

CONTACT

0046 8 517 75 600nils.wahlgren@karolinska.se

Daniel Strbian, Dr.

CONTACT

Daniel.Strbian@hus.fi

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2013

First Posted

March 15, 2013

Study Start

January 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

March 15, 2013

Record last verified: 2013-03

Locations

SE(1)