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Evaluation of a Novel Method for Hematocrit Level Determination

NCT ID: NCT01026883

Last Updated: 2014-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2012-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Healthy subjects

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

Group Type OTHER

Blood draw

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Gerhard Garhofer

Assoc. Prof. Priv. - Doz. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gerhard Garhofer, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Pharmacology, Medical University of Vienna

Locations

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Department of Clinical Pharmacology, Medical University of Vienna

Vienna, Vienna, Austria

Site Status

Countries

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Austria

Other Identifiers

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OPHT-290909

Identifier Type: -

Identifier Source: org_study_id