Stroke, AcuteTRUST CTNCT03634748
Thrombolysis in stRoke With Unknown onSet Based on noncontrasT CT
An observational study of Stroke, Acute, run by University Hospital Tuebingen at 5 sites in 4 countries.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute
- How many people
- 117 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 1 Sep 2017to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: wake-up stroke, unknown onset stroke
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
Slovakia2 sites
University Hospital Bratislava
Bratislava
General Hospital Liptovsky Mikulas
Liptovský Mikuláš
About this study
Official title: Thrombolysis in stRoke With Unknown onSet Based on Non-contrasT CT (TRUST CT). An International, Multicenter, Registry-based Study
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
Read the 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.
- Conditions
- Stroke, Acute
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
sICH
symptomatic ICH according to ECASS3
Measured: 72hours
Secondary outcomes (1)
mRS 90 days
mRS 90 days
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start1 Sep 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- St John of God Hospital, Vienna
- Responsible party
- Principal investigator, Dr. Sven Poli, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03634748
- Sponsor's protocol ID
- TRUST CT
- Acronym
- TRUST CT
- Status last verified
- Feb 2019
- First submitted
- 14 Aug 2018
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32067594
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thrombolysis in stRoke With Unknown onSet Based on Non-contrasT CT (TRUST CT). An International, Multicenter, Registry-based Study
- ClinicalTrials.gov ID
- NCT03634748
- Acronym / sponsor ID
- TRUST CT / TRUST CT
- Conditions
- Stroke, Acute
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- St John of God Hospital, Vienna
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 16 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- wake-up stroke, unknown onset stroke
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
sICH
Time frame: 72hours
symptomatic ICH according to ECASS3
1 secondary outcome
mRS 90 days
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
- Derived from this study: PubMed 32067594Sykora 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Acute, run by University Hospital Tuebingen at 5 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Slovakia, Austria, Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sICH (time frame: 72hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03634748, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2019.