All patients found eligible for thrombolysis may enter the thrombolysis-arm (NOR-SASS I), all patients with contraindications to thrombolysis within the 4 ½ hour time window may enter the no-thrombolysis-arm (NOR-SASS II). MedDRA version: 14.1 Level: PT Classification code 10061256 Term: Ischaemic stroke System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
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Sponsors
Helse Bergen, Haukeland University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria Patients 18 years or older with acute ischaemic stroke Treatment must be delivered within 4½ hours of symptom onset Patients who fulfil NOR-TEST criteria for iv thrombolysis are eligible for the CEST arm Patients who have a contraindication for thrombolysis are eligible for the CES arm Informed written consent signed by the patient, verbal consent from the patient as witnessed by a non-participating health care person, or consent by the signature of the patient's family must be provided before treatment. Patients for whom no informed consent can be obtained will not be included in the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 200
Exclusion criteria
Exclusion criteria: Exclusion criteria Patients with premorbid modified Rankin Scale (mRS) score =3; · Patients for whom a complete NIH Stroke Score cannot be obtained; · Hemiplegic migraine with no arterial occlusion on baseline CT; · Seizure at stroke onset and no visible occlusion on baseline CT; · Intracranial haemorrhage on baseline CT; · Clinical presentation suggesting subarachnoid haemorrhage even if baseline CT is normal; · Large areas of hypodense ischaemic changes on baseline CT; · Patients with primary endovascular treatment; · Female, pregnant or breast feeding; pericarditis; sepsis; any other serious medical illness likely to interact with treatment; confounding pre-existent neurological or psychiatric disease; unlikely to complete follow-up; any investigational drug 90 mmHg); uncontrolled hypertension; · moderate to severe COPD (baseline O2 saturation <80%); · acute respiratory distress syndrome (ARDS); · no temporal “bone window” for ultrasound examination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary analysis in NOR-SASS is to test whether Contrast enhanced sonothrombolysis (CEST) is superior to no CEST.;Secondary Objective: The specific aims of the NOR-SASS are to "Assess the effect on clinical short-term and long-term outcome of CEST "Assess safety of the chosen algorithm "Assess the effect on 2 hour and 24 hour recanalisation of combined CEST and intravenous thrombolysis versus intravenous thrombolysis alone. "Assess the effect on 2 hour and 24 hour recanalisation of CEST versus no specific treatment ;Primary end point(s): Periodic safety review is performed after each 40 enrolled patients. (20 per group) Functional handicap (modified Rankin Scale score) at 90 days;Timepoint(s) of evaluation of this end point: After each 40 enrolled patients. On day 90. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): " Haemorrhagic transformation (haemorrhagic infarct / haematoma) " Symptomatic cerebral haemorrhage " Major neurological improvement at 24-36 hours " Recanalisation at 2 hours and " Recanalisation at 24-36 hours Safety monitoring is performed by an independent Data safety and monitoring committee (DSMC). Periodic safety review is performed after each 40 enrolled patients (20 per group). Formal interim analysis is performed once a year. If the DSMC finds unacceptably increased symptomatic intracerebral haemorrhage (SICH) with [CEST+TNK 0,4 mg/kg], i.e. a 2% excess of SICH as compared with [CEST+tPA], the tier 0,4 mg/kg will be stopped and the study continued with TNK 0,25 mg/kg. If [CEST+any thrombolysis] shows a 2% excess of SICH as compared with [any thrombolysis], the study will be stopped. The same stopping rule will be applied to [CES] vs. [sham CES] in patients not eligible for thrombolysis.;Timepoint(s) of evaluation of this end point: At 2 hours At 24-36 hours | — |
Countries
Norway
Contacts
Public ContactLars Thomassen
Haukeland University Hospital, Helse Bergen
Outcome results
None listed