N/A
N=131
Noninvasive Hemoglobin Testing, Prospective Blood Donors
Healthy · Anemia
Bottom Line
View on ClinicalTrials.gov: NCT04450381 ↗Enrolled (actual)
131
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcome: Primary: Rad-67 Sensitivity — 44 percentage of sensitivity
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Rad-67 Pulse oximeter & DCI Mini sensor (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Masimo Corporation
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rad-67 Sensitivity |
44 | — |
| PRIMARY Rad-67 Specificity |
86.73 | — |
Summary
The objective of this clinical investigation is to evaluate the pulse oximeter devices for screening prospective blood donors. The purpose study is to report on the accuracy of noninvasive hemoglobin (SpHb) as compared to hemoglobin measurements obtained from a laboratory hematology analyzer in a blood donation setting.
Eligibility Criteria
Inclusion Criteria
- At least 18 years of age
- Weight at least 110 pounds
- Subjects with the intention of being screened for eligibility to donate blood
- The subject has given written informed consent to participate in the study
Exclusion Criteria
- Subjects with skin abnormalities at the planned application sites that may interfere with sensor application, per directions-for-use (DFU) or trans-illumination of the site, such as burns, scar tissue, infections, abnormalities, etc.
- Subjects unwilling and/or unable to remove nail polish or acrylic nails
- Subjects with blood cancers such as leukemia
- Subjects with hemoglobin disorders such as sickle-cell anemia and thalassemia
- Subjects with known history of infectious diseases such as HIV/AIDS, syphilis, hepatitis, etc.
- Subjects with self-disclosed/known pregnancy at the time of enrollment
- Subjects deemed not suitable for the study at the discretion of the investigator
- Excessive motion includes postural changes, making hand gestures, involuntary muscular movements, etc.
Data sourced from ClinicalTrials.gov (NCT04450381). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.