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

January 2, 2024 updated by: Umeå University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard
A regular standard dialysis is performed and held as active comparator for analysis
Other: Standard
Standard dialysis set is used as comparative
Experimental: Emboless

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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of change in air micro bubbles during hemodialysis
Time Frame: 1 year
Numbers of air micro bubbles (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 change 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
adverse events
Time Frame: 1 year
If a patient experience adverse events these will be reported
1 year
Comparison of change in air micro bubbles for hemodialysis versus hemodiafiltration
Time Frame: 1 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Umeå University

Investigators

  • Principal Investigator: Ulf Forsberg, MD, PhD, Region Vasterbotten Skelleftea Hospital, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 11, 2022

Primary Completion (Estimated)

March 15, 2024

Study Completion (Estimated)

March 15, 2024

Study Registration Dates

First Submitted

November 6, 2023

First Submitted That Met QC Criteria

December 4, 2023

First Posted (Actual)

December 13, 2023

Study Record Updates

Last Update Posted (Estimated)

January 3, 2024

Last Update Submitted That Met QC Criteria

January 2, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIV-20-02-031667

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We can share data upon reasonable request.

IPD Sharing Time Frame

Expected time of completing data is 1 year from now.

IPD Sharing Access Criteria

Reasonable request to share information such as safety analyses, repeating studies or control authorities.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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