NCT02711332

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 17, 2016

Completed
Last Updated

March 17, 2016

Status Verified

March 1, 2016

Enrollment Period

Same day

First QC Date

November 24, 2015

Last Update Submit

March 11, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Measured potassium concentration in capillary blood tests compared to venous blood tests.

    1 hour

Secondary Outcomes (2)

  • Correlation from fHb and potassium

    1 hour

  • Degree of haemolysis in capillary blood tests compared to venous blood tests.

    1 hour

Study Arms (1)

Degree of Haemolysis

Each subject will have four capillary blood sampling on different fingers. A reference venous blood sampling will be conducted.

Other: capillary blood samplingOther: venous blood sampling

Interventions

Each subject will have four capillary blood collections on different fingers. A reference venous blood collection will be conducted.

Also known as: capillary blood sampling on fingertips
Degree of Haemolysis

Each subject will have four capillary blood collections on different fingers. A reference venous blood collection will be conducted.

Also known as: blood sampling
Degree of Haemolysis

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Communtiy Sample

You may qualify if:

  • Male or female
  • Healthy
  • Signed informed consent before any trial-related activities

You may not qualify if:

  • Severe acute and/or chronic diseases
  • Mental incapacity, unwillingness of language barriers precluding adequate understanding or cooperation
  • Pregnancy or breastfeeding
  • Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hemolysis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Julia Mader, Prof.Dr.

    Medical University of Graz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2015

First Posted

March 17, 2016

Study Start

June 1, 2015

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

March 17, 2016

Record last verified: 2016-03