Cerebrovascular StrokeDIAGLUICTUS2NCT04297345
Feasibility and Safety Study to Evaluate the Neuroprotective Effect of Hemodialysis in Acute Ischemic Stroke
A study testing Hemodialysis in people with Cerebrovascular Stroke, run by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa at 1 site in Spain.
Trial 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 have demonstrated that peritoneal dialysis is an effective technique to reduce blood glutamate levels and reduce… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cerebrovascular Stroke
- What is being tested?
- Hemodialysis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2021to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
José Vivancos Mora, MD., PhD
Madrid, 28006
Mónica Sobrado, PhD, 915202416, sobrado.m@gmail.com
About this study
Official title: Feasibility, Safety, Randomized, Controlled, Open-label Study to Evaluate the Neuroprotective Effect of Hemodialysis of Plasma Glutamate and Proinflammatory Cytokines in the Acute Phase of Ischemic Stroke
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 have demonstrated that peritoneal dialysis is an effective technique to reduce blood glutamate levels and reduce infarct volume.
The objective of this clinical trial is to evaluate the viability, safety and efficacy of hemodialysis in patients with acute ischemic stroke, proposing that it may have a) a potential neuroprotective effect by reducing the excitotoxic levels of glutamate and proinflammatory cytokines in blood and b) fewer technical problems than peritoneal dialysis to apply in usual clinical practice.
Read the 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 brain infarct in a model of focal cerebral ischemia in rats; b) PD is effective in reducing plasma Glu levels in patients with chronic renal failure; c) PD is a safe and well tolerated procedure in patients with ischemic stroke in the acute phase, however, it was not a viable procedure in our conditions, due to the malfunction of the automatic system that made it difficult for the inclusion sessions and dialysate extraction and the difficulty for the collaboration of this type of patient with the procedure; d). The increase in the median concentration of Glu after cerebral infarction was reduced to 46% after PD.
Based on our previous results, the investigators believe that hemodialysis may have fewer technical problems than PD and serve as a neuroprotection technique by lowering the levels of Glu and proinflammatory cytokines in blood. To do this, the investigators establish the following objectives: a) To evaluate the feasibility and safety of a hemodialysis procedure in patients with acute ischemic stroke compared to a control group; b) To analyze the clinical benefit of hemodialysis estimated by the volume of the infarction and the neurological and functional situation of the patients; and c) To measure the levels of glutamate and proinflammatory cytokines in plasma and dialysate samples. For this, a single-center, randomized, open-label, controlled study has been designed with a group of patients with ischemic stroke who receive conventional treatment (N=10) or conventional treatment + 2 hemodialysis sessions (N=10) in the acute phase of the stroke (Phase IIa clinical trial with medical device).
- Conditions
- Cerebrovascular Stroke
- Being tested
- Hemodialysis
- Keywords
- hemodialysis neuroprotection, glutamate, proinflammatory cytokines, clinical trial, safety and efficacy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemodialysisDevice
Also called extracorporeal blood purification technique
Blood enters the extracorporeal circuit from the arterial line of the femoral catheter. For this the investigators use a pump integrated in the monitor, equipped with control systems, exerting a negative pressure.
Subsequently, it enters the dialyzer through the internal part of the capillaries (porous), producing a passive exchange of inflammatory and oxidative substances (such as cytokines) with the dialysis fluid, which also circulates through the dialyzer, but through the external part of the capillaries. Blood is returned to the patient, through the venous line of the catheter, with a lower concentration of cytokines after passing through the dialyzer.
This circuit is repeated continuously during the 3 hours of the procedure to ensure maximum clearance of glutamate and interleukins, among other substances.
| Study group | Role | What they receive |
|---|---|---|
| hemodialysis group | Experimental | The active group will include patients with acute ischemic stroke who, in addition to conventional treatment (best possible medical treatment in patients admitted to a stroke unit), will undergo two hemodialysis sessions for a period of about 3 hours each session in the acute phase of stroke.
The investigators will perform a conventional and heparin-free hemodialysis using high-flow dialyzers to avoid possible adverse (allergic) reactions with polysulfones containing other dialyzers. Receives: Device: Hemodialysis |
| control group | No intervention | The control group will be composed of patients with similar clinical and demographic characteristics to whom only conventional medical treatment will be applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint: Percentage estimation of mortality
Reported here is the percentage of participants who died due to any cause during the study.
Mortality will be compared between randomized groups in an intention-to-treat fashion
Measured: Day 90
Primary Safety Endpoint: Number of adverse effects
An adverse event (AE) is defined as an undesirable medical occurrence in a participant of clinical research that does not necessarily have a causal relationship with this treatment. An AE can be a sign, symptom, laboratory finding, or result of an abnormal test.
Adverse effects number will be compared between randomized groups in an intention-to-treat fashion
Measured: Day 90
Primary Safety Endpoint: Percentage of participants with early neurological impairment
Early neurological impairment: Increase of 4 or more points on the NIHSS scale during the first 24 hours after treatment. The National Institutes of Health Stroke Scale, or NIH Stroke Scale (NIHSS) is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.
NIHSS score will be compared between randomized groups in an intention-to-treat fashion
Measured: Day 7
Primary Safety Endpoint: Percentage of participants with symptomatic bleeding transformation
The incidence rate of intracranial hemorrhages on follow-up CT. The incidence rate will be compared between randomized groups in an intention-to-treat fashion
Measured: Day 3
Feasibility of hemodialysis procedure in stroke: participant adherence to hemodialysis procedure.
The study will be considered viable if the percentage of patients who complete their hemodialysis procedure is equal to or greater than 70%.
Measured: Day 3
Feasibility of hemodialysis procedure in stroke: Time of intervention
The study will be considered viable if, in at least 80% of patients, the time from randomization to the start of the hemodialysis treatment is not more than 2h.
Measured: Day 3
Secondary outcomes (7)
Efficacy of the first haemodialysis in the reduction of plasma Glu
Time course of Glu concentrations in plasma on each experimental arm. The first hemodialysis will be before 12 h from the start of the symptoms (if start is known) or before 12 h from the last time seen well (if start is not known). The first sample obtained will be assigned the time 0h of the first hemodialysis.
Glu concentrations will be compared between randomized groups in an intention-to-treat fashion
Measured: Hour 0, hour 0.5, hour 3, hour 3.5
Efficacy of the first haemodialysis in the reduction of plasma pro-inflammatory cytokines
Time course of pro-inflammatory cytokines (IL1, IL6, IL8 and TNFalpha) concentrations in plasma on each experimental arm.
The first hemodialysis will be before 12 h from the start of the symptoms (if start is known) or before 12 h from the last time seen well (if start is not known). The first sample obtained will be assigned the time 0h of the first hemodialysis.
Pro-inflammatory cytokines will be compared between randomized groups in an intention-to-treat fashion
Measured: Hour 0, hour 0.5, hour 3, hour 3.5
Efficacy of the second haemodialysis in the reduction of plasma Glu
Time course of Glu concentrations in plasma on each experimental arm. The second hemodialysis will be when the onset of symptoms is known: 24±3h from the onset of symptoms or, when the onset of symptoms is not known: 8-12h from the onset of the first HD. The first sample obtained will be assigned the time 0h of the second hemodialysis.
Glu concentrations will be compared between randomized groups in an intention-to-treat fashion
Measured: Hour 0, hour 0.5, hour 3, hour 3.5
Efficacy of the second haemodialysis in the reduction of plasma pro-inflammatory cytokines
Time course of pro-inflammatory cytokines concentrations (IL1, IL6, IL8 and TNFalpha) in plasma on each experimental arm.
The second hemodialysis will be when the onset of symptoms is known: 24±3h from the onset of symptoms or, when the onset of symptoms is not known: 8-12h from the onset of the first HD. The first sample obtained will be assigned the time 0h of the second hemodialysis.
Pro-inflammatory cytokines will be compared between randomized groups in an intention-to-treat fashion
Measured: Hour 0, hour 0.5, hour 3, hour 3.5
Efficacy of haemodialysis in the reduction of infarct volume
The change in infarct volume measured as the difference between the infarct core on multimodality CT input and infarct volume at 24±8h and 72h ±24h minus the infarct volume measured at input on single CT images will be calculated.
Infarct volume will be compared between randomized groups in an intention-to-treat fashion
Measured: Day 1, day 3
Percentage of participants with favourable evolution of the neurological deficit
The favourable evolution in the neurological deficit (NIHSS 0.1 or improvement ≥ 4 points) will be assessed with respect to that obtained 60 minutes after the complete completion of the reperfusion treatment carried out.
The National Institutes of Health Stroke Scale, or NIH Stroke Scale (NIHSS) is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.
The neurological deficit score will be compared between randomized groups in an intention-to-treat fashion
Measured: Day 7
Percentage of participants with good functional recovery as assessed by the Modified Rankin Scale
The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. A score of 0-2 represents good functional recovery. The scores are defined as follows: (0) No symptoms at all; (1) No significant disability despite symptoms, able to carry out all usual duties and activities; (2) Slight disability, unable to carry out all previous activities, but able to look after own affairs without assistance.
The mRS score will be compared between randomized groups in an intention-to-treat fashion
Measured: Month 3.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start1 Jan 2021
- Primary completionNov 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Controlled, Open-label The active group will include patients with acute ischemic stroke who, in addition to conventional treatment (best possible medical treatment in patients admitted to a stroke unit), will undergo two hemodialysis sessions in the acute phase of stroke. The control group will be composed of patients with similar clinical and demographic characteristics to whom only conventional medical treatment will be applied.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- José Vivancos, MD,PhD, Principal investigator, Instituto de Investigación Hospital la Princesa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04297345
- Sponsor's protocol ID
- JVM-HD-19
- Acronym
- DIAGLUICTUS2
- Status last verified
- Dec 2021
- First submitted
- 4 Feb 2020
- Last updated
- 3 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Safety, Randomized, Controlled, Open-label Study to Evaluate the Neuroprotective Effect of Hemodialysis of Plasma Glutamate and Proinflammatory Cytokines in the Acute Phase of Ischemic Stroke
- ClinicalTrials.gov ID
- NCT04297345
- Acronym / sponsor ID
- DIAGLUICTUS2 / JVM-HD-19
- Conditions
- Cerebrovascular Stroke
- Keywords
- hemodialysis neuroprotection, glutamate, proinflammatory cytokines, clinical trial, safety and efficacy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fundación de Investigación Biomédica - Hospital Universitario de La PrincesaUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 5 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 have demonstrated that peritoneal dialysis is an effective technique to reduce blood glutamate levels and reduce infarct volume.
The objective of this clinical trial is to evaluate the viability, safety and efficacy of hemodialysis in patients with acute ischemic stroke, proposing that it may have a) a potential neuroprotective effect by reducing the excitotoxic levels of glutamate and proinflammatory cytokines in blood and b) fewer technical problems than peritoneal dialysis to apply in usual clinical practice.
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 brain infarct in a model of focal cerebral ischemia in rats; b) PD is effective in reducing plasma Glu levels in patients with chronic renal failure; c) PD is a safe and well tolerated procedure in patients with ischemic stroke in the acute phase, however, it was not a viable procedure in our conditions, due to the malfunction of the automatic system that made it difficult for the inclusion sessions and dialysate extraction and the difficulty for the collaboration of this type of patient with the procedure; d). The increase in the median concentration of Glu after cerebral infarction was reduced to 46% after PD.
Based on our previous results, the investigators believe that hemodialysis may have fewer technical problems than PD and serve as a neuroprotection technique by lowering the levels of Glu and proinflammatory cytokines in blood. To do this, the investigators establish the following objectives: a) To evaluate the feasibility and safety of a hemodialysis procedure in patients with acute ischemic stroke compared to a control group; b) To analyze the clinical benefit of hemodialysis estimated by the volume of the infarction and the neurological and functional situation of the patients; and c) To measure the levels of glutamate and proinflammatory cytokines in plasma and dialysate samples. For this, a single-center, randomized, open-label, controlled study has been designed with a group of patients with ischemic stroke who receive conventional treatment (N=10) or conventional treatment + 2 hemodialysis sessions (N=10) in the acute phase of the stroke (Phase IIa clinical trial with medical device).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, Controlled, Open-label The active group will include patients with acute ischemic stroke who, in addition to conventional treatment (best possible medical treatment in patients admitted to a stroke unit), will undergo two hemodialysis sessions in the acute phase of stroke. The control group will be composed of patients with similar clinical and demographic characteristics to whom only conventional medical treatment will be applied.
| Arm | Type | Receives |
|---|---|---|
| hemodialysis group | Experimental | Device: HemodialysisThe active group will include patients with acute ischemic stroke who, in addition to conventional treatment (best possible medical treatment in patients admitted to a stroke unit), will undergo two hemodialysis sessions for a period of about 3 hours each session in the acute phase of stroke. The investigators will perform a conventional and heparin-free hemodialysis using high-flow dialyzers to avoid possible adverse (allergic) reactions with polysulfones containing other dialyzers. |
| control group | No intervention | –The control group will be composed of patients with similar clinical and demographic characteristics to whom only conventional medical treatment will be applied. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HemodialysisAlso: extracorporeal blood purification techniqueBlood enters the extracorporeal circuit from the arterial line of the femoral catheter. For this the investigators use a pump integrated in the monitor, equipped with control systems, exerting a negative pressure. Subsequently, it enters the dialyzer through the internal part of the capillaries (porous), producing a passive exchange of inflammatory and oxidative substances (such as cytokines) with the dialysis fluid, which also circulates through the dialyzer, but through the external part of the capillaries. Blood is returned to the patient, through the venous line of the catheter, with a lower concentration of cytokines after passing through the dialyzer. This circuit is repeated continuously during the 3 hours of the procedure to ensure maximum clearance of glutamate and interleukins, among other substances. | Device | hemodialysis group |
Primary outcome
Primary Safety Endpoint: Percentage estimation of mortality
Time frame: Day 90
Reported here is the percentage of participants who died due to any cause during the study. Mortality will be compared between randomized groups in an intention-to-treat fashion
Primary Safety Endpoint: Number of adverse effects
Time frame: Day 90
An adverse event (AE) is defined as an undesirable medical occurrence in a participant of clinical research that does not necessarily have a causal relationship with this treatment. An AE can be a sign, symptom, laboratory finding, or result of an abnormal test. Adverse effects number will be compared between randomized groups in an intention-to-treat fashion
Primary Safety Endpoint: Percentage of participants with early neurological impairment
Time frame: Day 7
Early neurological impairment: Increase of 4 or more points on the NIHSS scale during the first 24 hours after treatment. The National Institutes of Health Stroke Scale, or NIH Stroke Scale (NIHSS) is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0. NIHSS score will be compared between randomized groups in an intention-to-treat fashion
Primary Safety Endpoint: Percentage of participants with symptomatic bleeding transformation
Time frame: Day 3
The incidence rate of intracranial hemorrhages on follow-up CT. The incidence rate will be compared between randomized groups in an intention-to-treat fashion
Feasibility of hemodialysis procedure in stroke: participant adherence to hemodialysis procedure.
Time frame: Day 3
The study will be considered viable if the percentage of patients who complete their hemodialysis procedure is equal to or greater than 70%.
Feasibility of hemodialysis procedure in stroke: Time of intervention
Time frame: Day 3
The study will be considered viable if, in at least 80% of patients, the time from randomization to the start of the hemodialysis treatment is not more than 2h.
7 secondary outcomes
Efficacy of the first haemodialysis in the reduction of plasma Glu
Time frame: Hour 0, hour 0.5, hour 3, hour 3.5
Efficacy of the first haemodialysis in the reduction of plasma pro-inflammatory cytokines
Time frame: Hour 0, hour 0.5, hour 3, hour 3.5
Efficacy of the second haemodialysis in the reduction of plasma Glu
Time frame: Hour 0, hour 0.5, hour 3, hour 3.5
Efficacy of the second haemodialysis in the reduction of plasma pro-inflammatory cytokines
Time frame: Hour 0, hour 0.5, hour 3, hour 3.5
Efficacy of haemodialysis in the reduction of infarct volume
Time frame: Day 1, day 3
Percentage of participants with favourable evolution of the neurological deficit
Time frame: Day 7
Percentage of participants with good functional recovery as assessed by the Modified Rankin Scale
Time frame: Month 3.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José Vivancos, MD,PhD principal investigator
Instituto de Investigación Hospital la Princesa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemodialysis in people with Cerebrovascular Stroke, run by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Monica Sobrado, PhD (+34915202416, sobrado.m@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Endpoint: Percentage estimation of mortality (time frame: Day 90). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2022.