Thrombolysis in stRoke With Unknown onSet Based on noncontrasT CT (TRUST CT)

University Hospital Tuebingen

Status: Completed

Conditions: Stroke, Acute

Study type: Observational

Funder types: Other

Identifiers

NCT03634748

TRUST CT

Details and patient eligibility

About

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

Full 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.

Enrollment: 117 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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