The Norwegian Sonothrombolysis in Acute Stroke Study Part 2

Summary

BACKGROUND: Thrombolytic drugs may dissolve blood vessel clots in acute ischemic stroke. The overall benefit of intravenous thrombolysis is substantial, but up to 2/3 of patients with large clots may not achieve re-opening of the vessel and up to 40% of the patients may remain severely disabled or die. Ultrasound accelerates clot break-up (lysis) when combined with thrombolysis (sonothrombolysis) and increases the likelihood of functional independence at 3 months. Adding intravenous ultrasound contrast (gaseous microspheres) further enhances the thrombolytic effect (contrast enhanced sonothrombolysis = CEST). Contrast enhanced ultrasound may also accelerate clot break-up in the absence of thrombolytic drugs (contrast enhanced sonolysis = CES).

HYPOTHESIS: Contrast enhanced ultrasound treatment administered within 4 1/2 hours after symptom onset may be given safely to patients with acute ischemic stroke, both to those receiving intravenous thrombolysis and those not receiving intravenous thrombolysis, and will improve clinical outcome.

AIMS: To compare efficacy and safety of contrast enhanced ultrasound treatment vs. no ultrasound treatment in patients with acute ischemic stroke receiving or not receiving intravenous thrombolysis.

STUDY ENDPOINTS: The primary endpoints are 1) neurological improvement at 24 hours (proof of concept) and 2) excellent clinical outcome at 3 months (effect). Secondary endpoints are bleeding complications (safety), brain damage (infarct size/location) and early clinical improvement (effect).

Conditions

• Ischemic Stroke

Interventions

OTHER

Ultrasound

SonoVue solution 10 ml (2 vials / 80 µl microbubbles) is given as an infusion of 0,3 ml/min for \~30 minutes, using a Bracco infusion pump.

OTHER

Sham ultrasound

Mounting the ultrasound headframe but connecting this to a non-operative channel

Sponsors & Collaborators

• University of Bergen

  collaborator OTHER

• Sykehuset Telemark

  collaborator OTHER_GOV

• Haukeland University Hospital

  lead OTHER

Principal Investigators

• Lars Thomassen, MD PhD Prof. · Dept. Neurology, Haukeland University Hospital, Bergen, Norway

• Christopher E Kvistad, MD · Dept. Neurology, Haukeland University Hospital, Bergen, Norway

• Haakon Tobro, MD · Dept. Neurology, Sykehuset Telemark, Skien

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-01-31

Primary Completion

2019-12-31

Completion

2019-12-31

Countries

• Norway

Study Locations