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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03634748

Acronym

TRUST CT

Enrollment

117

Registered

2018-08-16

Start date

2017-09-01

Completion date

2018-12-31

Last updated

2019-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke, Acute

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
sICH	72hours	symptomatic ICH according to ECASS3

Secondary

Measure	Time frame	Description
mRS 90 days	90 days	mRS 90 days

Countries

Austria, Germany, Slovakia, Switzerland

Outcome results