Thrombolysis in stRoke With Unknown onSet Based on noncon... | NCT03634748

Studies
Thrombolysis in stRoke With Unknown onSet Based on noncontrasT CT

NCT03634748

Sponsor

University Hospital Tuebingen

Status

Completed

Last Update Posted

Feb 4, 2019Actual

Enrollment

117Actual

Phase

Not provided

Conditions

Stroke, Acute

Interventions

Not provided

Countries

Austria
Germany
Slovakia
Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2017Actual

Primary Completion Date

Dec 31, 2018Actual

Completion Date

Dec 31, 2018Actual

First Submitted Date

Aug 14, 2018

First Submission Date that Met QC Criteria

Aug 15, 2018

First Posted Date

Aug 16, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 1, 2019

Last Update Posted Date

Feb 4, 2019Actual

Name	Class
St John of God Hospital, Vienna	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

117Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
mRS 90 days	mRS 90 days	90 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion:

Ischemic stroke with NIHSS ≥ 4
Wake-up stroke or unknown onset stroke
Age ≥ 18 years
rtPA Bolus within 4.5h of awakening and/or within 4.5 of discovering symptoms
rtPA Bolus within 30 min. of admission CT

Exclusion:

Noncontrast cranial CT scan with ASPECTS < 7
Evidence of intracranial or subarachnoid hemorrhage
Inability to control systolic BP >185mm Hg, or diastolic BP >110mm Hg with IV antihypertensive medication
Known coagulopathy or evidence of active bleeding
Surgical procedures, subclavian arterial puncture, trauma, and gastrointestinal or genitourinary bleeding within 14 days of the event
Patients taking oral anticoagulants and having an INR >1.7
A platelet count <100 000, venous glucose either <50 or >450
Premorbid mRS > 3

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

wake-up stroke, unknown onset stroke

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St. Johns Hospital Vienna		Vienna			Austria
University Hospital Tuebingen

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32067594	Derived	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.

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases