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NCT04285775

A Novel Device for Surveillance of Vascular Access Sites for Bleeding

Completed Last updated 28 January 2021
What this trial tests

trial testing Application of device which monitors for bleeding - Blood Warning Technology with Continuous Hemoglobin sensor (BWATCH) in Dialysis; Complications in 250 participants. Completed in 30 June 2020.

Timeline
1 March 2019
Primary endpoint
30 June 2020
30 June 2020

Quick facts

Lead sponsorChangi General Hospital
StatusCompleted
Study typeOBSERVATIONAL
Enrollment250
Start date1 March 2019
Primary completion30 June 2020
Estimated completion30 June 2020
Sites1 location across Singapore

Drugs / interventions tested

Conditions studied

Sponsor

Changi General Hospital

Who can join

21 and older, any sex, with Dialysis; Complications or Wound Complication. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background Bleeding is often encountered after vascular access procedures for dialysis and fatal episodes of haemorrhage has been reported. A technological solution was sought to monitor for such rare but potentially catastrophic incidents. A novel device, BWATCH, was developed to detect fresh blood from wounds. Aims The aim of this clinical trial was to evaluate the sensitivity and specificity of the device in detecting bleeding in a clinical environment. Methods This a prospective, observational study on inpatients who will have a dialysis catheter inserted or removed. The device will be placed over the dressing for at least 6 hours. An alarm will be triggered if the device detects moisture and wavelength of light reflected specific for haemoglobin.

Publications & conference data

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

  1. A device for surveillance of vascular access sites for bleeding: results from a clinical evaluation trial.
    Chionh CY, Soh DY, Tan CH, Khaw JY, et al · · 2020 · cited 1× · PMID 33097747 · DOI 10.1038/s41598-020-74571-2

Verify or expand the search:

Other recruiting trials for Dialysis; Complications

Currently open trials in the same condition.

Other Changi General Hospital trials

Trials by the same sponsor.

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Data sources for this page

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