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Evaluation of a Novel Method for Hematocrit Level Determination

This study has been terminated.
Information provided by (Responsible Party):
Gerhard Garhofer, Medical University of Vienna Identifier:
First received: December 4, 2009
Last updated: November 13, 2014
Last verified: November 2014

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.

Condition Intervention
Other: Blood draw

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Evaluation of a Novel Method for Hematocrit Level Determination

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Correlation of hematocrit level determined by two different techniques [ Time Frame: 5 minutes ]

Enrollment: 51
Study Start Date: April 2010
Study Completion Date: November 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01026883

Department of Clinical Pharmacology, Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Principal Investigator: Gerhard Garhofer, MD Department of Clinical Pharmacology, Medical University of Vienna
  More Information

Responsible Party: Gerhard Garhofer, Assoc. Prof. Priv. - Doz. Dr., Medical University of Vienna Identifier: NCT01026883     History of Changes
Other Study ID Numbers: OPHT-290909
Study First Received: December 4, 2009
Last Updated: November 13, 2014

Keywords provided by Medical University of Vienna:
layered resonant piezoelectric sensors processed this record on April 27, 2017