An observational study in Blood Tests, sponsored by Radiometer Medical ApS. Completed at 2 sites in Denmark. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-24.
Sponsored by Radiometer Medical ApS · Observational
Conducting the ABL90 FLEX PLUS Clinical Precision Study for ctBil and FHbF Parameters in Neonatal Whole Blood is to validate performance claims for precision of the ABL90 FLEX PLUS ctBil and FHbF parameters in neonatal whole blood while being influenced by testing environment that is representative of intended use environment, site variability, intended use testing environment and operator variability in a Point-of-Care (POC) setting.
The investigational device is the ABL90 FLEX PLUS incl. consumables, running SW3.5 MR2, manufactured by Radiometer Medical ApS.
The study is being conducted in Denmark and in total, a minimum of 54 subjects are to be enrolled to provide successful measurement values from 3 different sites.
The conduct of the clinical study is to determine the repeatability of ctBil and FHbF parameters in neonatal whole blood using contrived fetal cord blood from umbilical cord/placenta measured by the intended users in syringe, short probe, and capillary modes available for ABL90 FLEX PLUS, in a POC setting.
The primary endpoint is the Repeatability (SD) for each parameter, parameter level and measuring mode, pooled across sites.
Participating sites are maternity wards or similar site conducting planned cesarean sections. Pregnant women 18 years of age or older admitted to the maternity ward to undergo cesarian section after week 38 of gestation will be enrolled in the clinical study. When the subject has signed ICF, the site will collect cord blood from umbilical cord/placenta and when relevant prepare contrived samples by having access to adult type 0 Rh neg whole blood for diluting HbF in cord blood.
Three POC users, such as a nurse, a physician, or a therapist that care for the woman in the maternity ward will perform all measurements and they shall contribute evenly to the total number of samples measured. Replicate measurements shall be performed by the same user.
6-10 mL of cord blood is collected in a blood collection syringe from each umbilical cord/placenta, contrived, and the sample is aliquoted into 5 safePICO aspirators (max volume 1.5 mL) or into 25 capillary tubes.
At each site, samples will be collected for the 2 parameters, 3 modes and 3 levels, completing measurements from minimum of 18 samples from 18 subjects.
Radiometer Medical ApS is the lead sponsor of 18 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Pregnant women 18 years of age or older admitted to the maternity ward to undergo cesarian section after week 38 of gestation.
Exclusion Criteria:
The ABL90 FLEX PLUS analyzer is a portable, automated analyzer that measures pH, blood gases, electrolytes, metabolites, and oximetry in whole blood - utilizing 3 measuring modes (syringe, short probe, and capillary mode) to measure samples from a syringe, test tube or a capillary tube. The analyzer provides results for 17 parameters in 35 seconds using 65 μL heparinized whole blood.
ABL90 FLEX PLUS Clinical Precision
Repeatability (SD) for each parameter (ctBil and FHbF), parameter level and measuring mode, pooled across sites.
Time frame: 5 hours
Plan to share: Yes — When the Clinical Study Report has been finalized, Data result will be available for public on platforms and in articles.
Supporting information: Csr
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Radiometer Medical ApS