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NCT03539861 · ClinicalTrials.gov registry record · NA
Immunomodulatory Biomimetic Device to Treat Myocardial Stunning in End-stage Renal Disease Patients
A NA study, sponsored by University of Michigan.
- Terminated
- Registry status
- NA
- Development phase
- 2
- Enrollment target
NCT03539861: Clinical Trial NA study, sponsored by University of Michigan.
NCT03539861 is a NA study that was terminated before completion, run by University of Michigan. The registered enrollment target is 2 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03539861, a NA study, was terminated before completion, sponsored by University of Michigan.
- TERMINATED
- Registry status
- NA
- Development phase
- 2 participants
- Enrollment target
Study Summary
Hemodialysis is a therapy that filters waste, removes extra fluid and balances electrolytes. In hemodialysis, blood is removed from the body and filtered through a man-made membrane called a dialyzer, and then the filtered blood is returned to the body. Hemodialysis is associated with injury to the heart muscle called myocardial stunning. This may occur for many reasons, including removal of fluid during dialysis or low blood pressure. Initial ischemia and subsequent white blood cell infiltration into the injured myocardium play a critical role in the degree of myocardial ischemia reperfusion injury. In this study an additional man made membrane (selective cytopheretic device) and tubing will be added to the dialysis circuit. The device shifts the circulating white blood cells pool to a less inflammatory phenotype. Researchers believe the selective cytopheretic device will alter the phenotype of circulating white blood cells which play a role in myocardial stunning. The purpose of this study is to evaluate whether the selective cytopheretic device will reduce myocardial stunning events in hemodialysis patients. It will also report the rate of adverse events.
Primary Outcome
Regional wall motion will be scored using a standard wall motion scoring scheme. (1= normal; 2=hypokinetic; 3= akinetic; 4=dyskinetic). Scores will be tabulated for each of 16 predefined segments and a global wall motion score calculated as the sum of individual scores divided by the number visualized segments.
Interventions
- DEVICE Hemodialysis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2019-09-24 |
| Est. Completion | 2021-08-04 |
| Phase | NA |
Why NCT03539861 stopped before completion
NCT03539861 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which Hemodialysis is the first listed.
NCT03539861 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03539861 about?
NCT03539861 is a clinical study titled "Immunomodulatory Biomimetic Device to Treat Myocardial Stunning in End-stage Renal Disease Patients". Hemodialysis is a therapy that filters waste, removes extra fluid and balances electrolytes. In hemodialysis, blood is removed from the body and filtered through a man-made membrane called a dialyzer, and then the filtered blood is returned to the body. Hemodialysis is associated with injury to the ...
What is the current status of trial NCT03539861?
This trial is currently terminated. It is a NA study. The enrollment target is 2 participants. The study started on 2019-09-24. Estimated completion is 2021-08-04.
What interventions are being tested in trial NCT03539861?
The interventions under investigation include: Hemodialysis (DEVICE).
Who is sponsoring clinical trial NCT03539861?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03539861's enrollment target sits among peer trials
2 1997th of 2000 the lowest of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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