NCT06168539

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

Completed NA Last updated 11 December 2024

What this trial tests

NA trial testing Emboless in Hemodialysis Complication in 20 participants. Completed in 10 December 2024.

Timeline

11 May 2022

Primary endpoint
10 May 2024

10 December 2024

Quick facts

Lead sponsor	Umeå University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	prevention
Enrollment	20
Start date	11 May 2022
Primary completion	10 May 2024
Estimated completion	10 December 2024
Sites	1 location across Sweden

Drugs / interventions tested

• Emboless
• Standard

Conditions studied

• Hemodialysis Complication — all drugs for Hemodialysis Complication →
• Air Embolism — all drugs for Air Embolism →
• Extracorporeal Circulation; Complications — all drugs for Extracorporeal Circulation; Complications →

Sponsor

Umeå University

Who can join

18 and older, any sex, with Hemodialysis Complication or Air Embolism. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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 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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The Emboless® venous chamber efficiently reduces air bubbles: a randomized study of chronic hemodialysis patients.
   Forsberg U, Jonsson P, Stegmayr B. · · 2024 · cited 1× · PMID 39574541 · DOI 10.1093/ckj/sfae323