STUDY OF SAFETY AND VIABILITY TO EVALUATE THE POTENTIAL NEUROPROTECTIVE EFFECT OF PERITONEAL DYALISIS IN THE STROKE

Phase 1

• Conditions: BRAIN ISCHEMIC STROKE IN ACUTE PHASE; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2012-000791-42-ES
• Lead Sponsor: FUNDACION INVESTIGACION BIOMEDICA HOSPITAL UNIVERSITARIO LA PRINCESA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-29
• Last Update Posted: 17 May 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients 18 to 80 years-old with acute ischemic stroke in the territory of the middle cerebral artery, which can not be applied pharmacological thrombolysis or mechanical thrombectomy, with less than 12h duration and have given consent.
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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

-Patients with previous functional dependency (mRS>2),
-presence of minor neurological deficit (NIHSS scale < 4 at the time of randomization) or rapid improvement during the process of inclusion,
-very severe neurological deficit (NIHSS>20),
-state of coma,
- posterior territory stroke;
- lacunar stroke with symptoms (pure hemiparesis, pure hemihypoestesia, dysarthria, clumsy hand, ataxia, hemiparesis),
-haematological diseases, infectious, inflammatory or neoplastic known at the time of treatment,
-pregnancy or lactation (urine analysis be performed prior to randomization in women of childbearing age),
-renal impairment (CLcr < 40 ml/h o Creat > 1.5 mg/dl) previously known;
- severe liver disease, any comorbility status at the discretion of the investigator may prevent the patient complete the study;
-hours of stroke onset unknown (in stroke upon awakening is taken as the start time of the last time the patient was seen asymptomatic);
-contraindication to standard procedure of peritoneal dialysis,
-haemorrhagic stroke in the imaging scan performed at baseline,
-stroke or myocardial infarction within the previous 90days,
-platelet count<100.000/mm3,
-treatment with anticoagulants
- INR < 1.4 or Time cephalin > 1.3 times the control group,
-participation in another clinical trial within the previous 90 days.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified