Acute Ischemic StrokeHAISMNCT03454867
Hemofiltration in Acute Ischemic Stroke
A study testing Hemofiltration and Standard acute ischemic stroke treatment in people with Acute Ischemic Stroke, run by University Medical Center, Kazakhstan.
Trial summary
Ischemic stroke is accompanied by a three to four hundred percent increase in the brain's extracellular fluid (ECF) and cerebrospinal fluid (CSF) concentration of glutamate, which diffuses and damages surrounding neurons. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Hemofiltration and Standard acute ischemic stroke treatment
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2014to 31 Jan 2015
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 75 year-old; both males and females;
- Diagnosis of acute ischemic stroke verified by CT or MRI and moderate to severe disability (NIHSS 5-21 points, GCS > 4 points and < 12);
- Able to start hemofiltration treatment within 12 hours of stroke onset.;
- Signed written informed consent in either Kazakh or Russian.
Who cannot join
- Age below 18 years or above 75 years;
- Presentation over 12 hours from stroke onset;
- Decompensated coronary heart disease (unstable angina, acute myocardial infarction, heart failure - according to New York or Canadian classification, 3, blood disorders, known coagulopathy, platelet count less than75 000 / mmc;
- Pulmonary edema, shock, hemodynamic instability;
- Intracranial hemorrhage or lesions (brain abscess, tumors);
- Inability to obtain informed consent;
- Pregnancy;
- Contraindications for CT.
About this study
Official title: Hemofiltration in Acute Ischemic Stroke Management
Ischemic stroke is accompanied by a three to four hundred percent increase in the brain's extracellular fluid (ECF) and cerebrospinal fluid (CSF) concentration of glutamate, which diffuses and damages surrounding neurons. In this study we tested our hypothesis that blood glutamate levels can be reduced by hemofiltration, resulting in increased extracellular clearance of glutamate and attenuated neurodegeneration, and that decreased blood glutamate levels can provide significant neuroprotection against stroke-associated neurodegeneration, dysfunction and death. Our primary outcome of interest was to assess safety of hemofiltration in acute ischemic stroke patients.
Read the detailed description
Ethical Conduct of the Study
Investigator Responsibilities
The principle investigator was responsible for monitoring and responding to adverse events, ethical participant use, compliance with the protocols and any protocol amendments, decisions to end the study early and compliance with data and sample management protocols. CO-PI was trained in both local and international requirements and standards and assisted and report to the PI on these tasks.
Participant Selection and Enrollment
Eligible participants were identified by medical staff at the ICU or emergency department. Enrollment will be standardized and directed by Co-PI.
Screening for Eligibility
A screening log was completed for all eligible patients. Data including inclusion criteria met, exclusion criteria not met and date consent obtained was collected on this form. It was kept in a locked cabinet at the center.
Informed Consent
The informed consent form was available in both Russian and Kazakh languages and was approved by the Institutional Research Ethics Committee (IREC) before use.
Monitoring for safety (hemofiltration-related adverse events (HRAE). All adverse events which occurred during the course of HF including the serious adverse events (SAE) were documented and analyzed. The attending physicians as well as the chief of neurocritical care unit and the principal investigator were responsible for screening for HRAE. In case if any of HRAE occurred all research team members as well as the chief of ICU and the medical director of the hospital were informed. All HRAEs were analyzed by the research team members and the medical director of the hospital. The patients were screened for the following adverse events: hypotension, hypertension, cardiac dysrhythmia, hypothermia or hyperthermia, disorders of water-electrolyte and acid-base balance, bleeding disorders, hemorrhagic transformation of acute ischemic stroke.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Hemofiltration, Standard acute ischemic stroke treatment
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemofiltrationDevice
Standard acute ischemic stroke treatmentProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Hemofiltration (treatment) | Experimental | Standard acute ischemic stroke treatment + hemofiltration Standard treatment included thrombolytic therapy for eligible candidates (tPA 0,9 mg/kg, max dose 90 mg) Receives: Device: Hemofiltration; Procedure: Standard acute ischemic stroke treatment |
| Control | Active comparator | Standard acute ischemic stroke treatment Standard treatment included thrombolytic therapy for eligible candidates (tPA 0,9 mg/kg, max dose 90 mg) Receives: Procedure: Standard acute ischemic stroke treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety monitoring for adverse events
The patients were screened continuously for the following adverse events: death, bleeding disorders, hemorrhagic transformation of acute ischemic stroke, central line-related blood stream infection, cardiac dysrhythmia within 28 days
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2018
- Study start1 Jun 2014
- Primary completion31 Jan 2015
- Study completion31 Jan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic 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
- Hemofiltration protocol. Hemofiltration was started after all enrollment criteria (informed consent, inclusion/exclusion criteria checklists, registration and assignment to treatment arm) had been met . Vascular access was secured by inserting an 11F double lumen catheter (GamCath, Gambro, Germany) into the jugular, femoral or subclavian vein. CVVH (continuous veno-venous hemofiltration) was carried out using a hemofiltration machine (Fresenius Multifiltrate, Germany). In all patients a 1.9 m2 highly permeable cellulose triacetate hemofilter was used (NIPRO UF205, Nissho corporation, Japan). All patients were treated by CVVH with the predilution mode; the blood flow was set at 180 ml/min.
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center, Kazakhstan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dmitriy Viderman, University Medical Center, Kazakhstan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03454867
- Sponsor's protocol ID
- Hemoinstroke
- Acronym
- HAISM
- Status last verified
- Feb 2018
- First submitted
- 16 Feb 2018
- Last updated
- 6 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will work on method of data sharing
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemofiltration in Acute Ischemic Stroke Management
- ClinicalTrials.gov ID
- NCT03454867
- Acronym / sponsor ID
- HAISM / Hemoinstroke
- Conditions
- Acute Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University Medical Center, KazakhstanUniversity, hospital or other
- Study start
- 1 Jun 2014 (actual)
- Primary completion
- 31 Jan 2015 (actual)
- Study completion
- 31 Jan 2015 (actual)
- First posted
- 6 Mar 2018 (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.
Ischemic stroke is accompanied by a three to four hundred percent increase in the brain's extracellular fluid (ECF) and cerebrospinal fluid (CSF) concentration of glutamate, which diffuses and damages surrounding neurons. In this study we tested our hypothesis that blood glutamate levels can be reduced by hemofiltration, resulting in increased extracellular clearance of glutamate and attenuated neurodegeneration, and that decreased blood glutamate levels can provide significant neuroprotection against stroke-associated neurodegeneration, dysfunction and death. Our primary outcome of interest was to assess safety of hemofiltration in acute ischemic stroke patients.
Detailed description
Ethical Conduct of the Study
Investigator Responsibilities
The principle investigator was responsible for monitoring and responding to adverse events, ethical participant use, compliance with the protocols and any protocol amendments, decisions to end the study early and compliance with data and sample management protocols. CO-PI was trained in both local and international requirements and standards and assisted and report to the PI on these tasks.
Participant Selection and Enrollment
Eligible participants were identified by medical staff at the ICU or emergency department. Enrollment will be standardized and directed by Co-PI.
Screening for Eligibility
A screening log was completed for all eligible patients. Data including inclusion criteria met, exclusion criteria not met and date consent obtained was collected on this form. It was kept in a locked cabinet at the center.
Informed Consent
The informed consent form was available in both Russian and Kazakh languages and was approved by the Institutional Research Ethics Committee (IREC) before use.
Monitoring for safety (hemofiltration-related adverse events (HRAE). All adverse events which occurred during the course of HF including the serious adverse events (SAE) were documented and analyzed. The attending physicians as well as the chief of neurocritical care unit and the principal investigator were responsible for screening for HRAE. In case if any of HRAE occurred all research team members as well as the chief of ICU and the medical director of the hospital were informed. All HRAEs were analyzed by the research team members and the medical director of the hospital. The patients were screened for the following adverse events: hypotension, hypertension, cardiac dysrhythmia, hypothermia or hyperthermia, disorders of water-electrolyte and acid-base balance, bleeding disorders, hemorrhagic transformation of acute ischemic stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Hemofiltration protocol. Hemofiltration was started after all enrollment criteria (informed consent, inclusion/exclusion criteria checklists, registration and assignment to treatment arm) had been met . Vascular access was secured by inserting an 11F double lumen catheter (GamCath, Gambro, Germany) into the jugular, femoral or subclavian vein. CVVH (continuous veno-venous hemofiltration) was carried out using a hemofiltration machine (Fresenius Multifiltrate, Germany). In all patients a 1.9 m2 highly permeable cellulose triacetate hemofilter was used (NIPRO UF205, Nissho corporation, Japan). All patients were treated by CVVH with the predilution mode; the blood flow was set at 180 ml/min.
| Arm | Type | Receives |
|---|---|---|
| Hemofiltration (treatment) | Experimental | Device: Hemofiltration, Procedure: Standard acute ischemic stroke treatmentStandard acute ischemic stroke treatment + hemofiltration Standard treatment included thrombolytic therapy for eligible candidates (tPA 0,9 mg/kg, max dose 90 mg) |
| Control | Active comparator | Procedure: Standard acute ischemic stroke treatmentStandard acute ischemic stroke treatment Standard treatment included thrombolytic therapy for eligible candidates (tPA 0,9 mg/kg, max dose 90 mg) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 to 75 year-old; both males and females;
- Diagnosis of acute ischemic stroke verified by CT or MRI and moderate to severe disability (NIHSS 5-21 points, GCS > 4 points and < 12);
- Able to start hemofiltration treatment within 12 hours of stroke onset.;
- Signed written informed consent in either Kazakh or Russian.
Key exclusion criteria (8 listed)
- Age below 18 years or above 75 years;
- Presentation over 12 hours from stroke onset;
- Decompensated coronary heart disease (unstable angina, acute myocardial infarction, heart failure - according to New York or Canadian classification, 3, blood disorders, known coagulopathy, platelet count less than75 000 / mmc;
- Pulmonary edema, shock, hemodynamic instability;
- Intracranial hemorrhage or lesions (brain abscess, tumors);
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 |
|---|---|---|
| Hemofiltration | Device | Hemofiltration (treatment) |
| Standard acute ischemic stroke treatment | Procedure or surgery | Control, Hemofiltration (treatment) |
Primary outcome
Safety monitoring for adverse events
Time frame: 28 days
The patients were screened continuously for the following adverse events: death, bleeding disorders, hemorrhagic transformation of acute ischemic stroke, central line-related blood stream infection, cardiac dysrhythmia within 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2018.
- Individual participant dataSharing planned: No. We will work on method of data sharing
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Hemofiltration and Standard acute ischemic stroke treatment in people with Acute Ischemic Stroke, run by University Medical Center, Kazakhstan.
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 4 inclusion and 8 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: finished, as of the sponsor's last update on 6 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety monitoring for adverse events (time frame: 28 days). 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 6 Mar 2018.