Evaluation of a Novel Method for Hematocrit Level Determination

Healthy Clinical Trial

Official title:

Evaluation of a Novel Method for Hematocrit Level Determination

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01026883
• Other study ID #: OPHT-290909
• Status: Terminated
• Phase: N/A
• First received: December 4, 2009
• Last updated: November 13, 2014
• Start date: April 2010
• Est. completion date: November 2012

Study information

• Verified date: November 2014
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 51
• Est. completion date: November 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

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.

Locations

Country	Name	City	State
Austria	Department of Clinical Pharmacology, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of hematocrit level determined by two different techniques		5 minutes	No