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OpenTrials
Completed

NCT Number: NCT04450381

Noninvasive Hemoglobin Testing, Prospective Blood Donors

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.

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Key information

Conditions

Healthy Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Blood Bank - Site 1

San Diego, California, 92102, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rad-67 Pulse oximeter & DCI Mini sensor

Device

Noninvasive pulse oximeter that measures hemoglobin

Primary outcomes

  1. Rad-67 Sensitivity

    Time frame: Up to one hour per subject

    Sensitivity of the the Rad-67 will be determined for its use in a blood donation center

  2. Rad-67 Specificity

    Time frame: Up to one hour per subject

    Specificity of the the Rad-67 will be determined for its use in a blood donation center

Sponsors and collaborators

Lead sponsor

Masimo Corporation

Industry

Registry information

Official study title

Noninvasive Hemoglobin Testing in Prospective Blood Donors

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 29, 2020
Registry last updated
Jul 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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