Status:
UNKNOWN
Feasibility and Safety Study to Evaluate the Neuroprotective Effect of Hemodialysis in Acute Ischemic Stroke
Lead Sponsor:
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Conditions:
Cerebrovascular Stroke
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
Hemodialysis is a therapeutic strategy used in subjects with chronic renal failure. Our working hypothesis is based on results published in experimental animal models of stroke where the investigators...
Detailed Description
The reason for the present study is based on previous data from the group that demonstrated the following results: a) The decrease in plasma Glu, by peritoneal dialysis (PD), reduces the size of the b...
Eligibility Criteria
Inclusion
- Patients older than 18 years.
- Acute ischemic stroke confirmed by multimodal CT due to occlusion of a large caliber artery in the intracranial internal carotid and / or M1 and / or tandem half-portion cerebral artery.
- ASPECTS between 4-10 in the CT scan without contrast of admission.
- Patients should be treated by mechanical thrombectomy, with or without prior treatment with rtPA-iv, with a final \>=TICI 2b result.
- Patients to whom pharmacological thrombolytic treatment (rt-PA) and/or mechanical thrombectomy is applied and their NIHSS is ≥ 8 at 60 minutes having completely finished the reperfusion treatment performed.
- \<12 h from the onset of symptoms to the start of treatment by hemodialysis or the inclusion in the arm of conventional medical treatment. Those patients with uncertain or unknown time of onset of symptoms may be included in the study provided that the same in the multimodal CT scan is\> = 50%
- The participants have granted their consent.
Exclusion
- Patients with prior important functional dependence (mRS\> 3);
- Presence of a minor neurological deficit (NIHSS scale\< 8 at the time of randomization);
- Coma state;
- Ischemic stroke of posterior territory;
- Hemorrhagic stroke in the neuroimaging test performed at the beginning;
- Pregnancy or lactation (urinalysis will be performed prior to randomization in women of childbearing age);
- Hematological, infectious, inflammatory or chronic neoplastic diseases known at the time of treatment;
- Patients with severe chronic renal failure on hemodialysis (stage 5D)
- Severe liver disease (ascites or coagulopathy, for example);
- Any serious, advanced or terminal illness with an expected life expectancy of less than 6 months;
- Any comorbidity situation that, at the discretion of the investigator, may prevent the patient from completing the study;
- Stroke or myocardial infarction in the previous 90 days;
- Platelet count \<100,000 / mm3;
- Anticoagulated patients who, in the opinion of the Nephrologist, the establishment of the central route for performing hemodialysis poses a high risk of bleeding;
- Participation in another clinical trial in the previous 90 days.
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04297345
Start Date
January 1 2021
End Date
December 1 2022
Last Update
January 3 2022
Active Locations (1)
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1
José Vivancos Mora, MD., PhD
Madrid, Spain, 28006