euroEPO-Stroke. Phase I-II
- Conditions
- Stroke
- Registration Number
- RPCEC00000185
- Lead Sponsor
- Center of Molecular Immunology, CIMAB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
1.Both sex
2.Age between 18 and 80 years
3.NIHSS between 5 and 20
4.Score between 0 and 1 in the consciousness subscore of NIHSS
5.Upper airway permeable
6.Time between the onset of symptoms and treatment must be lower than 8 hours. Estimated from the information supplied by the patient or its relative:
-If onset during sleep, the time of going bed will be taken.
-If the patient can not communicate, the last time when the patient was seen well will be taken
7.Informed consent
1.Presence of observable initial CT hyperdense lesion, whether by intraparenchymatous hemorrhage or cerebral infarction with hemorrhagic transformation
2.Isolated Neurological defects such as: ataxia, loss of sensation, dysarthria, or minimal muscle weakness.
3.Patients with symptoms or neurological signs that back to normal before the start of treatment.
4.Suspicion of inflammatory vascular diseases as a cause of the current Ischemic Brain Infarction (IBI) (lupus and other collagen diseases).
5.Trauma of skull or intracranial surgery recent (less than 4 weeks).
6.Known coagulation disorders.
7.Severe and uncontrolled arterial hypertension (diastolic >110 mm Hg or systolic >220) who does not descend after treatment.
8.Patients where proven coexistence of another disease or process that may lead to significant disability (cancer, septic embolism, endocarditis, malignant hypertension , Myeloproliferative disease, Creatinine >3 mg/dl, Hyperkalaemia > 5.0 mmol/L)
9.Patients with a history of hypersensitivity to the EPO-hr.
10.Pregnant or breastfeeding women.
11.Patients with a known allergy to any of the active substances that make up the product.
12.Patients presenting with nasal irritation (sneezing) or nasal discharge before starting treatment.
13.Patients who have asthma at the time of the initiation of treatment.
14.Patients who are receiving treatment with rTPA.
15.Signs of dysfunction of the brainstem.
16.Patients with severe liver disorders.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Seriousness of Advese Events (Serious/No serious). Time of measurement: Daily during Admission, 1 month, 3 months<br>Neurological recovery (Recovered/Non recovered). Time of measurement: 7 days, 1 month, 3 months
- Secondary Outcome Measures
Name Time Method