Evaluation of a Novel Method for Hematocrit Level Determination

The hematocrit level is defined as the ratio of plasma volume and red blood cell mass. Determination of this level is important for the diagnosis and follow-up of various hematological and renal disorders. In clinical practice, automated hematology analyzers are commonly used.

Recently, a new method for hematocrit level determination has been introduced which employs layered resonant piezoelectric sensors. In the present study this technique will be applied in blood samples of healthy subjects and compared to a standard laboratory method.

Study Overview

• Status: Terminated
• Conditions: Healthy
• Intervention / Treatment: Other: Blood draw

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Department of Clinical Pharmacology, Medical University of Vienna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Men and women aged between 18 and 80 years
• Men and women will be included in equal parts
• Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant

Exclusion Criteria:

• Symptoms of a clinically relevant illness in the 3 weeks before the study day
• Systemic treatment with anticoagulants
• Intake of any medication that could lead to spurious hematocrit values
• Presence of any medical condition that could lead to spurious hematocrit values
• Blood or plasma donation during the previous 3 weeks

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

OTHER: Healthy subjects; Hematocrit level of each subject will be assessed by two different techniques

Other: Blood draw; A venous blood sample will be taken (15 ml). Blood will be collected in 5 tubes. To avoid hematocrit variations due to the blood draw procedure, the first tube will be discarded. After that, the tourniquet which is used for venipuncture will be removed and 4 EDTA tubes (each 3 ml) will be filled with blood for hematocrit determination, one tube will be sent to the Department of Laboratory Medicine, and the other ones will be processed at the Department of Clinical Pharmacology.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Correlation of hematocrit level determined by two different techniques	5 minutes

Collaborators and Investigators

• Sponsor: Medical University of Vienna

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (ACTUAL): August 1, 2011
• Study Completion (ACTUAL): November 1, 2012

Study Registration Dates

• First Submitted: December 4, 2009
• First Submitted That Met QC Criteria: December 4, 2009
• First Posted (ESTIMATE): December 7, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): November 14, 2014
• Last Update Submitted That Met QC Criteria: November 13, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: hematocrit; layered resonant piezoelectric sensors
• Other Study ID Numbers: OPHT-290909