Thrombolysis in stRoke With Unknown onSet Based on noncontrasT CT

University Hospital Tuebingen117 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

117

Conditions

Stroke, Acute

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion: 1. Ischemic stroke with NIHSS ≥ 4 2. Wake-up stroke or unknown onset stroke 3. Age ≥ 18 years 4. rtPA Bolus within 4.5h of awakening and/or within 4.5 of discovering symptoms 5. rtPA Bolus within 30 min. of admission CT Exclusion: 1. Noncontrast cranial CT scan with ASPECTS \< 7 2. Evidence of intracranial or subarachnoid hemorrhage 3. Inability to control systolic BP \>185mm Hg, or diastolic BP \>110mm Hg with IV antihypertensive medication 4. Known coagulopathy or evidence of active bleeding 5. Surgical procedures, subclavian arterial puncture, trauma, and gastrointestinal or genitourinary bleeding within 14 days of the event 6. Patients taking oral anticoagulants and having an INR \>1.7 7. A platelet count \<100 000, venous glucose either \<50 or \>450 8. Premorbid mRS \> 3

Locations (5)

St. Johns Hospital Vienna

Vienna, Austria

University Hospital Tuebingen

Tübingen, Germany

University Hospital Bratislava

Bratislava, Slovakia

General Hospital Liptovsky Mikulas

Liptovský Mikuláš, Slovakia

Outcomes

Primary Outcomes

sICH

symptomatic ICH according to ECASS3

Time frame: 72hours

Secondary Outcomes

mRS 90 days

Time frame: 90 days

Data from ClinicalTrials.gov

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