NCT03634748

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2017

Geographic Reach
4 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 14, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 16, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

February 4, 2019

Status Verified

February 1, 2019

Enrollment Period

1.3 years

First QC Date

August 14, 2018

Last Update Submit

February 1, 2019

Conditions

Stroke, Acute

Outcome Measures

Primary Outcomes (1)

  • sICH

    symptomatic ICH according to ECASS3

    72hours

Secondary Outcomes (1)

  • mRS 90 days

    90 days

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

wake-up stroke, unknown onset stroke

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

St. Johns Hospital Vienna

Vienna, Austria

Location

University Hospital Tuebingen

Tübingen, 72076, Germany

Location

University Hospital Bratislava

Bratislava, Slovakia

Location

General Hospital Liptovsky Mikulas

Liptovský Mikuláš, Slovakia

Location

Lausanne University Hospital

Lausanne, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 32067594DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Director

Study Record Dates

First Submitted

August 14, 2018

First Posted

August 16, 2018

Study Start

September 1, 2017

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

February 4, 2019

Record last verified: 2019-02

Locations

AU(1)DE(1)SL(2)CH(1)