NCT03634748

Thrombolysis in stRoke With Unknown onSet Based on noncontrasT CT

Thrombolysis in stRoke With Unknown onSet Based on Non-contrasT CT (TRUST CT). An International, Multicenter, Registry-based Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 117 (actual)
• Sponsor: University Hospital Tuebingen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Stroke, Acute

Timeline

• Start date: 2017-09-01
• Primary completion: 2018-12-31
• Completion: 2018-12-31
• First posted: 2018-08-16
• Last updated: 2019-02-04

Locations

5 sites across 4 countries: Austria, Germany, Slovakia, Switzerland