Hemofiltration in Acute Ischemic Stroke

NCT ID: NCT03454867

Last Updated: 2018-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-01
• Study Completion Date: 2015-01-31

Brief 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. 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.

Conditions

Acute Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Hemofiltration

Intervention Type: DEVICE

Standard acute ischemic stroke treatment

Intervention Type: PROCEDURE

Control

Standard acute ischemic stroke treatment Standard treatment included thrombolytic therapy for eligible candidates (tPA 0,9 mg/kg, max dose 90 mg)

Group Type: ACTIVE_COMPARATOR

Standard acute ischemic stroke treatment

Intervention Type: PROCEDURE

Interventions

Hemofiltration

Intervention Type: DEVICE

Standard acute ischemic stroke treatment

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Center, Kazakhstan

OTHER

Sponsor Role: lead

Responsible Party

Dmitriy Viderman

Attending anesthesiologist & intensivist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Hemoinstroke

Identifier Type: -

Identifier Source: org_study_id