euroEPO in stroke

Phase 1

Suspended

• Conditions: STROKE; Ischemic stroke; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

• Registration Number: RPCEC00000282
• Lead Sponsor: Center of Molecular Immunology (CIM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-02
• Study Completion: 2024-02-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Suspended
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

1- Patients with ages equal to or greater than 19 years.
2- Patients with a score between 6 and 20 on the neurological scale NIHSS. They must have a score of 0 or 1 in the level of awareness section of said scale.
3- Have permeable airways.
4- Time elapsed between the onset of symptoms and the start of treatment = 24 hours. Calculated from the information provided by the patient or family member:
- If the debut occurs during sleep, it will be taken the time you went to sleep.
- If you can not communicate, by altering the language or speech, you will take the last hour when you saw it well.
5- Patients and / or relative or legal tutor who grant their consent to participate in the study.

Exclusion Criteria

1- Isolated neurological defects such as: ataxia, loss of sensitivity or minimal muscle weakness.
2-Patients with neurological symptoms or signs that return to normal before the start of treatment.
3-Suspected vascular inflammatory diseases as a cause of current ICTUS (lupus and other collagen diseases).
4-Skull trauma or recent intracranial surgery (less than 4 weeks).
5-Known coagulation disorders.
6-Severe and uncontrolled arterial hypertension (systolic> 220 or diastolic> 110 mm Hg) that does not descend after treatment.
7-Patients where coexistence of another disease or process leading to significant disability is demonstrated (cancer, septic embolism, endocarditis, malignant hypertension, myeloproliferative disease, creatinine> 3 mg / dl, hyperkalemia> 5.0 mmol / L).
8-Patients with a history of hypersensitivity to EPO-hr.
9-Women who are pregnant or breast-feeding.
10-Patients with a known allergy to any of the active substances that make up the product.
11-Patients who present nasal irritation (sneezing) or nasal discharge before starting treatment.
12-Patients who present asthma attacks at the time of treatment initiation.
13-Patients who are receiving rTPA treatment.
14-Signs of brain stem dysfunction.
15-Patients with severe liver disorders

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Serious adverse events with definite causal association, very probable or probable with the administration of the product. Measurement time: in each product administration, 3, 7 days, 1, 3, 6 months.<br>2. Degree of ICTUS (NIHHS scale). Measurement time: at baseline, 7 days, 1, 3 and 6 months.<br>3. Functional statu (Barthel index). Measurement time: 3 and 6 months.<br>4. Degree of disability (Rankin scale). Measurement time: 3 and 6 months.