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Intracranial EmbolismPhase 3NCT00336596

Ultrasound Enhanced Thrombolytic Therapy of Middle Cerebral Artery Occlusion

A Phase 3 study testing transcranial ultrasound in patients treated with iv t-PA in people with Intracranial Embolism and Thrombosis, run by University of Zurich at 6 sites in Switzerland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of the present, randomized, controlled multicenter phase III trial is to investigate the safety and efficacy of continuous 1-hour insonation of occluded middle cerebral artery with 2 MHz TCCS in stroke patients treated with intravenous tissue plasminogen activator (t-PA) within 3 hours after symptom onset. Read more about this study

Who is it for?
Any age
Conditions the study is for
Intracranial Embolism, Thrombosis
What is being tested?
transcranial ultrasound in patients treated with iv t-PA
How many people
400 participants
Where
6 sitesSwitzerland
Study dates
Jun 2006to Jun 2009
Phase
Phase 3
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • acute ischemic stroke in the MCA territory according to clinical and cranial computed tomography (CT) or cranial MR imaging (MRI) findings
  • patient undergoing iv thrombolysis with t-PA within 3 hours after stroke onset
  • Occlusion of sphenoidal (M1) or insular (M2) segment of the MCA at CT (CTA), MR (MRA) or catheter (CA) angiography
  • appropriate temporal bony window without echocontrast agents for insonation with TCCS
  • full functional independence prior to present stroke (mRS 0-1), use of a cane for walking due to comorbid condition is acceptable
  • written informed consent, signed and dated by the subject (or subject's authorized representative, if allowed by local laws) and by the person obtaining the consent, indicating agreement to comply with all protocol-specific procedures

Who cannot join

  • unconsciousness (more than 2 points on item 1a on NIHSS)
  • history of intracranial hemorrhage, arteriovenous malformation or aneurysm
  • severe cranio-cerebral trauma within the last 3 months
  • symptoms of subarachnoidal hemorrhage
  • time of symptom onset unclear
  • large surgical intervention or trauma within the last 10 days
Show all 17Show fewer
  • expected survival below 90 days after iv t-PA treatment
  • severe hepatic disease, esophageal varices, acute pancreatitis
  • septic embolism, endocarditis, pericarditis after myocardial infarction
  • pregnancy or childbirth within the last 30 days or nursing mothers
  • history of hemorrhagic diathesis or coagulopathy
  • untreatable increase of arterial blood pressure (>185mmHg systolic, >110mmHg diastolic)
  • intracranial hemorrhage, arteriovenous malformations or aneurysm at brain imaging
  • thrombocytes <100'000 per microliter
  • international normalized ratio (INR)>1.7 or partial thromboplastin time (PTT) prolongated
  • serum glucose <2.7mmol/l or >22.2mmol/l
  • severe renal insufficiency or other contraindications against CT-contrast agents

Trial locations and contacts

6 sites in 1 country.

Ralf W Baumgartner, MD contact

+41 1 255 56 86

ralf.baumgartner@usz.ch

6 sites in 1 country

Switzerland6 sites, 6 recruiting

  • Kantonsspital Aarau, Department of Neurology

    Aarau

    Hansjörg Hungerbühler, MD, +41 62 838 66 75, hansjoerg.hungerbuehler@ksa.ch

    Hansjörg Hungerbühler, MD

    Recruiting

  • University Hospital of Basel, Department of Neurology

    Basel

    Stefan Engelter, MD, +41 61 265 25 25, sengelter@uhbs.ch

    Philippe Lyrer, MD

    Recruiting

  • University hospital of Bern, Department of Neurology

    Bern

    Marcel Arnold, MD, +41 31 632 33 32, marcel.arnold@insel.ch

    H.-P. Mattle, MD

    Recruiting

  • University Hospital of Geneva, Department of Neurology

    Geneva

    Roman Sztajzel, MD, +41 22 372 83 10, Roman.Sztajzel@hcuge.ch

    Roman Sztajzel, MD

    Recruiting

  • University Hospital of Lausanne, Department of Neurology

    Lausanne

    Patrik Michel, MD, +41 21 314 11 85, patrik.michel@chuv.hospvd.ch

    Patrik Michel, MD

    Recruiting

  • University Hospital of Zurich, Department of Neurology

    Zurich, 8091

    Ralf W Baumgartner, MD, +41 1 255 56 86, ralf.baumgartner@usz.ch

    Dimitrios Georgiadis, MD, dimitrios.georgiadis@usz.ch

    Recruiting

Other trials in Switzerland

About this study

Official title: Transcranial Ultrasound Enhanced Thrombolysis (TRUST)

The purpose of the present, randomized, controlled multicenter phase III trial is to investigate the safety and efficacy of continuous 1-hour insonation of occluded middle cerebral artery with 2 MHz TCCS in stroke patients treated with intravenous tissue plasminogen activator (t-PA) within 3 hours after symptom onset.

Read the detailed description

Thrombolysis with intravenous(iv) tissue plasminogen activator (t-PA) is the only effective and approved therapy for acute ischemic stroke. The most frequent cause of ischemic stroke is thrombosis of the middle cerebral artery (MCA). Preliminary in vitro, animal and human studies suggest that ultrasound accelerates thrombolysis induced by t-PA, and recanalization of acute MCA occlusion due to thrombolysis is an independent predictor of good clinical outcome. Thus, insonation of an occluded MCA through the temporal bone in stroke patients who are treated with iv t-PA might enhance recanalization and improve clinical outcome. The present prospective, randomized, controlled multicenter pilot study will investigate the safety and efficacy of continuous 1-hour insonation of the occluded MCA with 2 MHz transcranial color duplex sonography in patients with ischemic stroke treated with iv t-PA within 3 hours after symptom onset. It is planned to randomize 400 patients in 6 Swiss centers during an enrolment period of 33 months with an individual follow up of 3 months. The study endpoints include safety and efficacy assessments. The primary safety endpoint is to determine the rate of symptomatic intracranial hemorrhage (ICH) in both treatment groups. The primary efficacy endpoint is to determine whether a good functional outcome (modified Rankin scale, mRs, score of 0-2) differs between both treatment groups. Secondary endpoints include (1) asymptomatic ICH occuring during or within the first 24-48 hours after t-PA infusion, (2) early clinical recovery by 10 or more National Institute of Health Stroke Scale (NIHSS) points or dramatic recovery (total NIHSS score of 3 or less) at 24-48 hours after t-PA infusion, (3) mean mRS score at 90 days after t-PA infusion, (4) death occuring during the study period, and (5) recanalization at 24-48 hours after t-PA infusion.

Being tested
transcranial ultrasound in patients treated with iv t-PA
Keywords
middle cerebral artery occlusion, intracranial embolism and thrombosis, ultrasound enhanced thrombolysis, Patients receiving iv thrombolytic therapy (t-PA)
Medical subject headings
Intracranial Embolism, Thrombosis, Infarction, Middle Cerebral Artery, Intracranial Embolism and Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • transcranial ultrasound in patients treated with iv t-PAProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Symptomatic intracranial hemorrhage (safety)

  2. Functional outcome (efficacy)

Secondary outcomes (5)

  1. Asymptomatic intracranial hemorrhage 24-48 hours after t-PA infusion

  2. Early clinical recovery by 10 or more NIHSS points or dramatic recovery (total NIHSS 3 or less)at 24-48 hours after t-PA infusion

  3. Mean mRS score at 90 days after t-PA infusion

  4. Death occurring during study period

  5. Recanalization at 24-48 hours after t-PA infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2006 (estimated)
  2. Study startJun 2006
  3. Study completionJun 2009 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
400 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00336596
Sponsor's protocol ID
E-031/2004
Status last verified
Apr 2007
First submitted
13 Jun 2006
Last updated
27 Apr 2007
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing transcranial ultrasound in patients treated with iv t-PA in people with Intracranial Embolism and Thrombosis, run by University of Zurich at 6 sites in Switzerland.

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 6 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 27 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ralf W Baumgartner, MD (+41 1 255 56 86, ralf.baumgartner@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Symptomatic intracranial hemorrhage (safety). The study lists 2 primary outcomes in all. 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 NCT00336596.

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 27 Apr 2007.

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