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Completed

NCT Number: NCT02976610

Clinical Study of a Novel Hemolysis Point of Care Test at an Emergency Department.

This study aims to investigate the outcome of hemolysis frequency when a hemolysis point of care test is introduced in an emergency department.

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Key information

Conditions

Hemolysis Blood Specimen Collection Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emergency department, Central Hospital Karlstad

Karlstad, Värmland County, 65230, Sweden

About this study

In a blood sample process, the preanalytical phase is accountable for a vast majority of laboratory test errors. Among preanalytical errors, hemolysis is the most frequent error of sample rejection. Recollection of blood from the patient causes extra suffering, increased turn-around-time hence delayed treatment, and unnecessary extra costs for the health care system.

Here is a novel method for hemolysis point of care detection (H-POCT) evaluated. The single use test is attached to the blood sample in direct conjunction to the sampling process.

Patients will be selected by consecutive selection at the emergency department if blood tests ordered by the physician meet the inclusion criteria. Patients will be randomized into one of two groups. All health care professionals participating in this study has attended in a standard education program in operating H-POCT.

If Allocated into the control group, n: 750, nurses and enrolled nurses will perform blood sample according to routine.

If allocated into the intervention group, n: 750, nurses and enrolled nurses will perform blood sample according to routine and screen all Lithium Heparin vacuum tubes. (for one or all of the analyzes: Liver status, Electrolytes and Troponin T.)

If the hemolysis point of care test (H-poct) indicate a positive test result the Lithium Heparin vacuum tube and the attached H-poct will be discarded and a new sample will be collected and screened for hemolysis until the user receives a negative sample that is not hemolyzed.

This study takes place in a county hospital with 430 beds and the emergency department treats 59000 patients yearly.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Blood sample analysis ordered:

  • Electrolyte
  • Troponin T
  • ALAT, ASAT, ALP.

Exclusion criteria

  • Incompletely filled tubes
  • Minors (< 18 years)
  • Patient not fit according to the health care professional assessment

Treatment and study plan

Hemolysis Point-of-Care test

Device

Hemolysis measurement of plasma using a point of care test to determine the hemolysis level in plasma

Primary outcomes

  1. Hemolysis frequency.

    Time frame: Through 52 weeks

    Compare the volume of hemolyzed blood samples in two groups.

Sponsors and collaborators

Lead sponsor

Hemcheck Sweden AB

Industry

Collaborators

  • Landstinget i Värmland

Registry information

Official study title

Open Label, Single Center Clinical Trial of a Novel Hemolysis Point of Care Test at an Emergency Department.

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 29, 2016
Registry last updated
Jun 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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