EUCTR2012-000323-41-NO
Active, not recruiting
Not Applicable
Randomised Trial of Contrast-enhanced Sonothrombolysis in acute ischaemic stroke - NOR-SASS
Helse Bergen, Haukeland University Hospital0 sitesApril 2, 2012
ConditionsAll patients found eligible for thrombolysis may enter the thrombolysis-arm (NOR-SASS I), all patientswith contraindications to thrombolysis within the 4 ½ hour time window may enter the no-thrombolysis-arm(NOR-SASS II).MedDRA version: 14.1Level: PTClassification code 10061256Term: Ischaemic strokeSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- All patients found eligible for thrombolysis may enter the thrombolysis-arm (NOR-SASS I), all patientswith contraindications to thrombolysis within the 4 ½ hour time window may enter the no-thrombolysis-arm(NOR-SASS II).
- Sponsor
- Helse Bergen, Haukeland University Hospital
- Status
- Active, not recruiting
- Last Updated
- 12 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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
Outcomes
Primary Outcomes
Not specified
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