Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Female or male inpatients.
Age: 18-80 years.
If female, patient must not be pregnant
Clinical diagnosis of ischemic stroke causing a measurable neurological deficit defined as impairment of language, motor function, cognition and/or gaze,vision or neglect. Ischemic stroke is defined as an event characterized by the sudden onset of an acute focal neurologic deficit presumed to be due to cerebral ischemia after CT scan excludes haemorrhage.
Onset of symptoms within 3 hours prior to initiation of rt-PA administration.
Stroke symptoms are to be present for at least 30 minutes and have not significantly improved before treatment. Symptoms must be distinguishable from an episode of generalized ischemia (i.e. syncope), seizure or migraine disorder.
Patient is willing to participate voluntarily and to sign a written patient informed consent. Informed consent will be obtained from each patient or the subject's legally authorized representative or relatives, or deferred where applicable, according to the regulatory and legal requirements of the participating country.
Patients who are unable to sign but who are able to understand the meaning of participation in the study may give an oral witnessed informed consent. These patients have to make clear undoubtful that they are willing to participate voluntarily and must be able to understand an explanation of the contents of the information sheet. A written consent has to be obtained as soon as possible.
Willingness and ability to comply with the protocol.

Exclusion Criteria:

Evidence of intracranial haemorrhage (ICH) on the CT-scan
Violation of inclusion criteria not approved by clinical study director or study safety officer
Failure to perform or to evaluate screening or baseline examinations
Hospitalisation (except for study purposes) or change of concomitant medication 4 weeks prior to screening or during screening period
Participation in another therapeutic clinical trial 3 months before baseline
Patients with any history of prior stroke and concomitant diabetes
Prior stroke within the last 3 months
Platelet count of below 100x103/mm3
Blood glucose <50 or >400 mg/dl (<2.77 or >22.15 mmol/L)
Known haemorrhagic diathesis
Manifest or recent severe or dangerous bleeding
Known bacterial endocarditis, pericarditis
Acute pancreatitis
Documented ulcerative gastrointestinal disease during the last 3 months, oesophageal varices, arterial-aneurysm, arterial/venous malformation
Neoplasm with increased bleeding risk
Severe liver disease, including hepatic failure, cirrhosis, portal hypertension, oesaphageal varices) and active hepatitis
Major surgery or significant trauma in past 3 months
Lab values seriously abnormal, and/or more than 2 lab values abnormal not approved by clinical study director or study safety officer
Serious drug allergies
Hypersensitivity to one of the components of the drug
Severe renal impairment
Systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg, or aggressive management (IV medication) necessary to reduce BP to these limits
Recent (less than 10 days) traumatic external heart massage, obstetrical delivery, recent puncture of a non-compressible blood-vessel (e.g. subclavian or jugular vein puncture)
Chronic intoxication or chronic substance use disorder with pharmaceuticals, drugs, alcohol or industrial poisons
Symptoms of ischemic attack began more than 3 hours prior to start of thrombolytic therapy or if time of symptom onset is unknown
Minor neurological deficit or symptoms rapidly improving before start of infusion
Severe stroke as assessed clinically (e.g. NIHSS >25) and/or by appropriate imaging techniques
Epilepsy or epileptic seizure at onset of stroke
Symptoms suggestive of subarachnoid haemorrhage, even if the CT-scan is normal
Known history of or suspected intracranial haemorrhage
Suspected subarachnoid haemorrhage or condition after subarachnoid hemorrhage from aneurysm
Any history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery)
Haemorrhagic retinopathy, e.g. in diabetes (vision disturbances may indicate haemorrhagic retinopathy)
Administration of heparin within the previous 48 hours and a thromboplastin time exceeding the upper limit of normal for laboratory
Patients receiving oral anticoagulants, e.g. warfarin sodium
Special attention should be given to possible additive effects when used in conjunction with anti-depressants or MAO-inhibitors
Cerebrolysin should not be mixed with balanced amino acid solutions in an infusion