Hemodialysis ComplicationNCT06168539
Reduction of Microemboli of Air Using a New Developed Air Trap (EmbolessTM) During Haemodialysis
A study testing Emboless and Standard in people with Hemodialysis Complication and Air Embolism, run by Umeå University at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis Complication, Air Embolism, Extracorporeal Circulation; Complications
- What is being tested?
- Emboless and Standard
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- 11 May 2022to 10 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read more
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.
Read the 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.
- Being tested
- Emboless, Standard
- Medical subject headings
- Embolism, Air
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmbolessOther
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.
StandardOther
Standard dialysis set is used as comparative
| Study group | Role | What they receive |
|---|---|---|
| Standard | Active comparator | A regular standard dialysis is performed and held as active comparator for analysis Receives: Other: Standard |
| Emboless | Experimental | 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. Receives: Other: Emboless |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of change in air micro bubbles during hemodialysis
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.
Measured: 1 year
Secondary outcomes (2)
Comparison of change in air micro bubbles 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.
Measured: 1 year
adverse events
If a patient experience adverse events these will be reported
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start11 May 2022
- Primary completion10 May 2024
- Study completion10 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hemodialysis ComplicationStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each patient is randomized to start with either standard or intervention vice versa. Paired analyses are done.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ulf Forsberg, MD, PhD, Principal investigator, Region Vasterbotten Skelleftea Hospital, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06168539
- Sponsor's protocol ID
- CIV-20-02-031667
- Status last verified
- Jan 2024
- First submitted
- 6 Nov 2023
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We can share data upon reasonable request.
Publications
Stegmayr BG. Sources of Mortality on Dialysis with an Emphasis on Microemboli. Semin Dial. 2016 Nov;29(6):442-446. doi: 10.1111/sdi.12527. Epub 2016 Aug 16.
PubMed 27528100Stegmayr B. Air contamination during hemodialysis should be minimized. Hemodial Int. 2017 Apr;21(2):168-172. doi: 10.1111/hdi.12474. Epub 2016 Aug 30.
PubMed 27576675Matsuda K, Fissell R, Ash S, Stegmayr B. Long-Term Survival for Hemodialysis Patients Differ in Japan Versus Europe and the USA. What Might the Reasons Be? Artif Organs. 2018 Dec;42(12):1112-1118. doi: 10.1111/aor.13363. Epub 2018 Nov 11. No abstract available.
PubMed 30417399Forsberg U, Jonsson P, Stegmayr B. Air contamination during medical treatment results in deposits of microemboli in the lungs: An autopsy study. Int J Artif Organs. 2019 Sep;42(9):477-481. doi: 10.1177/0391398819840363. Epub 2019 Apr 11.
PubMed 30973284Forsberg U, Jonsson P, Stegmayr B. Microemboli induced by air bubbles may be deposited in organs as a consequence of contamination during medical care. Clin Kidney J. 2022 Oct 6;16(1):159-166. doi: 10.1093/ckj/sfac217. eCollection 2023 Jan.
PubMed 36726427Jonsson P, Stegmayr C, Stegmayr B, Forsberg U. Venous chambers in clinical use for hemodialysis have limited capacity to eliminate microbubbles from entering the return bloodline: An in vitro study. Artif Organs. 2023 Jun;47(6):961-970. doi: 10.1111/aor.14495. Epub 2023 Jan 10.
PubMed 36594759
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Microemboli of Air Using a New Developed Air Trap (EmbolessTM) During Haemodialysis
- ClinicalTrials.gov ID
- NCT06168539
- Acronym / sponsor ID
- CIV-20-02-031667
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- 11 May 2022 (actual)
- Primary completion
- 10 May 2024 (actual)
- Study completion
- 10 Dec 2024 (actual)
- First posted
- 13 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Each patient is randomized to start with either standard or intervention vice versa. Paired analyses are done.
| Arm | Type | Receives |
|---|---|---|
| Standard | Active comparator | Other: StandardA regular standard dialysis is performed and held as active comparator for analysis |
| Emboless | Experimental | Other: EmbolessEmboless 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EmbolessEmboless has the US patent number 8894749 is compared to standard dialysis See also reference Jonsson et al 2023 referred to in the main text. | Other | Emboless |
| StandardStandard dialysis set is used as comparative | Other | Standard |
Primary outcome
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.
2 secondary outcomes
Comparison of change in air micro bubbles for hemodialysis versus hemodiafiltration
Time frame: 1 year
adverse events
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Background: PubMed 27528100Stegmayr BG. Sources of Mortality on Dialysis with an Emphasis on Microemboli. Semin Dial. 2016 Nov;29(6):442-446. doi: 10.1111/sdi.12527. Epub 2016 Aug 16.
- Background: PubMed 27576675Stegmayr B. Air contamination during hemodialysis should be minimized. Hemodial Int. 2017 Apr;21(2):168-172. doi: 10.1111/hdi.12474. Epub 2016 Aug 30.
- Background: PubMed 30417399Matsuda K, Fissell R, Ash S, Stegmayr B. Long-Term Survival for Hemodialysis Patients Differ in Japan Versus Europe and the USA. What Might the Reasons Be? Artif Organs. 2018 Dec;42(12):1112-1118. doi: 10.1111/aor.13363. Epub 2018 Nov 11. No abstract available.
- Results publication: PubMed 30973284Forsberg U, Jonsson P, Stegmayr B. Air contamination during medical treatment results in deposits of microemboli in the lungs: An autopsy study. Int J Artif Organs. 2019 Sep;42(9):477-481. doi: 10.1177/0391398819840363. Epub 2019 Apr 11.
- Results publication: PubMed 36726427Forsberg U, Jonsson P, Stegmayr B. Microemboli induced by air bubbles may be deposited in organs as a consequence of contamination during medical care. Clin Kidney J. 2022 Oct 6;16(1):159-166. doi: 10.1093/ckj/sfac217. eCollection 2023 Jan.
- Results publication: PubMed 36594759Jonsson P, Stegmayr C, Stegmayr B, Forsberg U. Venous chambers in clinical use for hemodialysis have limited capacity to eliminate microbubbles from entering the return bloodline: An in vitro study. Artif Organs. 2023 Jun;47(6):961-970. doi: 10.1111/aor.14495. Epub 2023 Jan 10.
- Individual participant dataSharing planned: Yes. We can share data upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulf Forsberg, MD, PhD principal investigator
Region Vasterbotten Skelleftea Hospital, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emboless and Standard in people with Hemodialysis Complication and Air Embolism, run by Umeå University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of change in air micro bubbles during hemodialysis (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06168539, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.