Clinical trial NCT03634748: Thrombolysis in stRoke With Unknown onSet Based on noncontrasT CT
Official title: Thrombolysis in stRoke With Unknown onSet Based on Non-contrasT CT (TRUST CT). An International, Multicenter, Registry-based Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke, Acute
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
Collaborators: name: St John of God Hospital, Vienna
First posted: 2018-08-16
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: wake-up stroke, unknown onset stroke

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.

Eligibility criteria: 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

Primary outcomes:
measure: sICH
timeFrame: 72hours
Secondary outcomes:
measure: mRS 90 days
timeFrame: 90 days
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: St. Johns Hospital Vienna
city: Tuebingen
country: Germany
facility: University Hospital Tuebingen
city: Bratislava
country: Slovakia
facility: University Hospital Bratislava
city: Liptovský Mikuláš
country: Slovakia
facility: General Hospital Liptovsky Mikulas
city: Lausanne
country: Switzerland
facility: Lausanne University Hospital
Study officials:
References:
citation: Sykora M, Kellert L, Michel P, Eskandari A, Feil K, Remi J, Ferrari J, Krebs S, Lang W, Serles W, Siarnik P, Turcani P, Kovacik M, Bender B, Mengel A, Poli K, Poli S. Thrombolysis in Stroke With Unknown Onset Based on Non-Contrast Computerized Tomography (TRUST CT). J Am Heart Assoc. 2020 Feb 18;9(4):e014265. doi: 10.1161/JAHA.119.014265. Epub 2020 Feb 12.