Hemofiltration in Acute Ischemic Stroke (HAISM)

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.

Study Overview

• Status: Completed
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Device: Hemofiltration; Procedure: Standard acute ischemic stroke treatment

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 Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 18 to 75 year-old; both males and females;
2. Diagnosis of acute ischemic stroke verified by CT or MRI and moderate to severe disability (NIHSS 5-21 points, GCS > 4 points and < 12);
3. Able to start hemofiltration treatment within 12 hours of stroke onset.;
4. Signed written informed consent in either Kazakh or Russian.

Exclusion Criteria:

1. Age below 18 years or above 75 years;
2. Presentation over 12 hours from stroke onset;
3. 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;
4. Pulmonary edema, shock, hemodynamic instability;
5. Intracranial hemorrhage or lesions (brain abscess, tumors);
6. Inability to obtain informed consent;
7. Pregnancy;
8. Contraindications for CT.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Hemofiltration (treatment); Standard acute ischemic stroke treatment + hemofiltration Standard treatment included thrombolytic therapy for eligible candidates (tPA 0,9 mg/kg, max dose 90 mg)	Device: Hemofiltration; Procedure: Standard acute ischemic stroke treatment
ACTIVE_COMPARATOR: Control; Standard acute ischemic stroke treatment Standard treatment included thrombolytic therapy for eligible candidates (tPA 0,9 mg/kg, max dose 90 mg)	Procedure: Standard acute ischemic stroke treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	28 days

Collaborators and Investigators

• Sponsor: University Medical Center, Kazakhstan

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2014
• Primary Completion (ACTUAL): January 31, 2015
• Study Completion (ACTUAL): January 31, 2015

Study Registration Dates

• First Submitted: February 16, 2018
• First Submitted That Met QC Criteria: March 5, 2018
• First Posted (ACTUAL): March 6, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 6, 2018
• Last Update Submitted That Met QC Criteria: March 5, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Cerebral Infarction
• Other Study ID Numbers: Hemoinstroke

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We will work on method of data sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No