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Thrombolysis in stRoke With Unknown onSet Based on noncontrasT CT

Completed
Conditions
Stroke, Acute
Registration Number
NCT03634748
Lead Sponsor
University Hospital Tuebingen
Brief Summary

Multicentric, observational, registry-based study of 0.9 mg/kg i.v. thrombolysis in wake-up stroke or stroke with unknown onset based on non-contrast CT appearance only

Detailed Description

Thrombolysis in wake-up stroke (WUS) or stroke with unknown onset (SUO) has been recently proven to be safe and effective using magnetic resonance imaging (MRI). However, in most of the thrombolyzing hospitals worldwide MR imaging is not available. We hypothesize that pragmatic non-contrast CT (NCCT)-based WUS/SUO thrombolysis may be feasible and safe.

Methods: TRUST-CT is an international multicenter registry-based study. WUS/SUO patients undergoing NCCT-based thrombolysis with NIHSS ≥ 4 and initial ASPECTS ≥ 7 are included and compared to propensity score matched non-thrombolyzed WUS/SUO controls. Primary endpoint is symptomatic intracranial hemorrhage (ICH); secondary endpoints include 24-hour NIHSS change of ≥ 4 and modified Rankin Score (mRS) at 90 days.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
117
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
sICH72hours

symptomatic ICH according to ECASS3

Secondary Outcome Measures
NameTimeMethod
mRS 90 days90 days

mRS 90 days

Trial Locations

Locations (5)

University Hospital Bratislava

🇸🇰

Bratislava, Slovakia

General Hospital Liptovsky Mikulas

🇸🇰

Liptovský Mikuláš, Slovakia

St. Johns Hospital Vienna

🇦🇹

Vienna, Austria

University Hospital Tuebingen

🇩🇪

Tuebingen, Germany

Lausanne University Hospital

🇨🇭

Lausanne, Switzerland

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