Thrombolysis in stRoke With Unknown onSet Based on noncontrasT CT

Stroke, Acute Clinical Trial

— TRUST CT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03634748
• Other study ID #: TRUST CT
• Status: Completed
• Start date: September 1, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: February 2019
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke
• Stroke, Acute

Locations

Country	Name	City	State
Austria	St. Johns Hospital Vienna	Vienna
Germany	University Hospital Tuebingen	Tuebingen
Slovakia	University Hospital Bratislava	Bratislava
Slovakia	General Hospital Liptovsky Mikulas	Liptovský Mikuláš
Switzerland	Lausanne University Hospital	Lausanne

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Tuebingen	St John of God Hospital, Vienna

Countries where clinical trial is conducted

Austria,  Germany,  Slovakia,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sICH	symptomatic ICH according to ECASS3	72hours
Secondary	mRS 90 days	mRS 90 days	90 days