Evaluation of a Novel Method for Hematocrit Level Determination

NCT01026883 | Terminated DMC

• 1 other identifier: OPHT-290909
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

hematocrit; layered resonant piezoelectric sensors

Outcome Measures

Primary Outcomes (1)

• Correlation of hematocrit level determined by two different techniques

  5 minutes

Study Arms (1)

Healthy subjects

OTHER

Hematocrit level of each subject will be assessed by two different techniques

Other: Blood draw

Interventions

Blood draw OTHER

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.

Healthy subjects

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, Vienna, 1090, Austria

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Gerhard Garhofer, MD

  Department of Clinical Pharmacology, Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Priv. - Doz. Dr.

Study Record Dates

• First Submitted: December 4, 2009
• First Posted: December 7, 2009
• Study Start: April 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: November 1, 2012
• Last Updated: November 14, 2014

Record last verified: 2014-11

Locations

AU (1)