Reduction of Microemboli of Air Using a New Developed Air Trap (EmbolessTM) During Haemodialysis

Study Overview
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Brief Summary
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During hemodialysis (HD) the blood of the patient pass an extracorporeal circuit that contains a dialyzer for rinsing and a venous chamber (air trap) to prevent from air embolism through the return blood into the patient. However, air traps in clinical use have limited capacity to prevent from microemboli of air to enter the return bloodline and deposit as emboli in the body such as lungs, heart and brain. The Investigator developed the air trap Emboless that was patented. In vitro studies showed significantly better reduction of microemboli contaminations than air traps compared to that in clinical use. The present randomized clinical trial compares two different air traps used by the same patients in a cross-over design (as pairs) using the Emboless compared with the Fresenius 4008/5008 (F5008). Chronic HD patients are randomized to perform the first HD with either their standard air trap (F5008) in the venous bloodline tubing or using the Emboless bloodline and vice versa. Each patient was included to make two paired series. A safety committee evaluates if significantly worse outcome appears especially with the Emboless, to stop the study. During HD the microbubbles are counted by a GAMPT ultrasound device using two probes. One probe is set at the inlet side of the air trap and the second at the outlet side. The outlet side represents data of microbubbles in the blood that are entering into the patient. Comparative non-parametric paired analyses are performed between the air traps. Monitoring of the study is performed.

Detailed Description
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During hemodialysis (HD) the blood of the patient pass an extracorporeal circuit that contains a dialyzer for rinsing and a venous chamber (air trap) to prevent from air embolism through the return blood into the patient. However, air traps in clinical use have limited capacity to prevent from microemboli of air to enter the return bloodline and deposit as emboli in the body such as lungs, heart and brain. The Investigator developed the air trap Emboless that was patented in Europe, USA and India. In vitro studies showed significantly better reduction of microemboli contaminations than air traps compared to that in clinical use. The present randomized clinical trial compares two different air traps used by the same patients in a cross-over design (as pairs) using the Emboless compared with the Fresenius 4008/5008 (F5008). Chronic HD patients are randomized to perform the first HD with either their standard air trap (F5008) in the venous bloodline tubing or using the Emboless bloodline and vice versa. Each patient is included to make two paired series. A maximum of 30 patients are planned. Each with 2 series of each two different sets of air traps that would give a total of 120 dialyses. A safety committee evaluates if significantly worse outcome appears especially with the Emboless. During HD the microbubbles are counted by a GAMPT ultrasound device using two probes. One probe is set at the inlet side of the air trap and the second at the outlet side. The outlet side represents data of microbubbles in the blood that are entering into the patient. Comparative non-parametric paired analyses are performed between the air traps. Monitoring of the study is performed.

Official Title
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Reduction of Microemboli of Air Using a New Developed Air Trap (EmbolessTM) During Haemodialysis

Conditions
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Hemodialysis Complication, Air Embolism, Extracorporeal Circulation; Complications

Intervention / Treatment
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* Other: Emboless
* Other: Standard


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Accepted are all patients performing chronic HD due to End Stage renal disease of any reason: 18 years and older accept, by consent, to participate in the study both genders, any ethnicity Exclusion Criteria: Patients that are expected not to fulfil a whole series of two dialysis within the study such as those: who suffer from active cancer or severe infection, cachexia or are planned for kidney transplantation close to the study period. patients that by any reason are considered inappropriate by the principal investigator, such as patients that experience severe hypotensive episodes during standard dialysis. Home-haemodialysis treatments and self-care dialysis treatments are not included in the study. If such patient accepts to participate in the study, he/she has to adapt to study criteria (assisted treatment).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Each patient is randomized to start with either standard or intervention vice versa. Paired analyses are done.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard<br>A regular standard dialysis is performed and held as active comparator for analysis | Other: Standard<br>* Standard dialysis set is used as comparative<br>|
| Experimental: Emboless<br>Emboless tubing set is part of the extracorporeal venous bloodline instead of the venous chamber by Fresenius (see standard above). For more information see reference Jonsson et al 2023- mentioned in references. | Other: Emboless<br>* Emboless has the US patent number 8894749 is compared to standard dialysis See also reference Jonsson et al 2023 referred to in the main text.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of air micro emboli contamination | Numbers of air microemboli (diameter sizes from 20-500µm diameter) are counted at inlet and outlet of the air trap with parallel probes using ultrasound GAMPT 200 device during 30minutes of HD. A calculation clarifies difference in percentage of outlet versus inlet amount/size of microbubble air return into the return bloodline that is connected to the return needle placed in the vein of the patient. The size in diameter and numbers within the dialysis time/30 minutes of HD are given. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of air contamination for hemodialysis versus hemodiafiltration | The Investigator aims to compare the microbubble reduction of the air traps also between the hemodialysis versus hemodiafiltration if the specific patient performs this dialysis under normal circumstances. | 1 year | 
| adverse events | If a patient experience adverse events these will be reported | 1 year |