Evaluation of a Novel Method for Hematocrit Level Determination

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Medical University of Vienna.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01026883
First received: December 4, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted
  Purpose

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
Healthy
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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: December 2009
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: December 2010 (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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01026883

Contacts
Contact: Gerhard Garhofer, MD 0043-1-40400 ext 2981 gerhard.garhoefer@meduniwien.ac.at

Locations
Austria
Department of Clinical Pharmacology, Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Gerhard Garhofer, MD    0043-1-40400 ext 2981    gerhard.garhoefer@meduniwien.ac.at   
Principal Investigator: Gerhard Garhofer, MD         
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Gerhard Garhofer, MD Department of Clinical Pharmacology, Medical University of Vienna
  More Information

No publications provided

Responsible Party: Gerhard Garhofer, Priv. Doz., MD, Department of Clinical Pharmacology
ClinicalTrials.gov Identifier: NCT01026883     History of Changes
Other Study ID Numbers: OPHT-290909
Study First Received: December 4, 2009
Last Updated: December 4, 2009
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Vienna:
hematocrit
layered resonant piezoelectric sensors

ClinicalTrials.gov processed this record on October 01, 2014