Evaluation of a Novel Method for Hematocrit Level Determination

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01026883

Enrollment

Registered

2009-12-07

Start date

2010-04-30

Completion date

2012-11-30

Last updated

2014-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

hematocrit, layered resonant piezoelectric sensors

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.

Interventions

OTHERBlood 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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

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

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026