Investigating the Influence of Haemolysis on the Potassium Concentration After Capillary Blood Sampling
Condition: Hemolysis
MeSH terms: Hemolysis
Study type: Observational

Summary: 
      This is an open, single-centre trial investigating the impact of haemolysis after capillary
      blood collection to the measured potassium concentration in Plasma healthy subjects. Each
      subject will have four capillary blood collections on different fingers. Two on the right and
      two on the left hand. Additionally as a reference a venous blood collection will be
      conducted.
    

Detailed description: 
      K@Home_1 a working package of the FFG project "K@Home - potassium home monitoring for
      patients with heart- and kidney insufficiency". In the project K@Home a potassium measuring
      system serveable by the patients even of the home monitoring should be developed.

      Aim from K@Home is to allow an everyday home monitoring of the potassium value by the
      development of potassium-test stripe, like with the diabetes patients who supervise their
      blood sugar level by measurements with glucose-test stripe from a drop of capillary blood
      from the finger berry and with it the emergencies and hospital admissions to reduce or to
      prevent. It is fact that haemolysis has a strong influence on the measured potassium
      concentration. It is likely that by using capillary blood a haemolysis appears and therefore
      distorted potassium concentrations are measured.

      In the study K@Home_1 it is a matter of evaluating, how high the degree of the haemolysis in
      capillary blood is, and in this fact to what extent leads to wrong potassium values. The
      results from this study will be a basic component for the sensor development.

      After clarification the approval the Informed Consent is signed and the inclusion as well as
      exclusion criteria (incl. demography, concomitant medication and medical history) or vital
      parameters (blood pressure, pulse, size, weight), are raised. An urine-pregnancy test is also
      carried out for the exclusion of a pregnancy in women capable of bearing children. It is not
      necessary that the subjects seem sober on the study day.

      With 22 healthy subjects capillary and venous blood is taken within the scope of one single
      study round. Blood is taken from the test persons by trained specialist staff of two
      fingertips of each hand (a total of four fingertips). The capillary blood sampling occurs in
      200 µ l Lithium-Heparin Sarsted Microvettes and in each case the first drop of blood is
      rejected. To guarantee a light blood decrease without strong mechanical pressure, the hands
      are warmed up before the capillary sampling required with the help of an electric blanket or
      by warm water roughly on room temperature.

      In addition 15 ml blood from the vein of a forearm is taken.
    

Intervention name(s): capillary blood sampling; venous blood sampling
Intervention type(s): Other; Other
Intervention description(s): Each subject will have four capillary blood collections on different fingers. A reference venous blood collection will be conducted.; Each subject will have four capillary blood collections on different fingers. A reference venous blood collection will be conducted.
Other intervention name(s): capillary blood sampling on fingertips; blood sampling
Observational model: Case-Only
Sampling method: Non-Probability Sample
Study population: 
        Communtiy Sample