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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02976610
Enrollment
1671
Registered
2016-11-29
Start date
2016-12-01
Completion date
2017-05-05
Last updated
2017-06-12

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

Conditions

Blood Specimen Collection, Hemolysis

Keywords

hemolysis

Brief summary

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

Detailed description

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.

Interventions

DEVICEHemolysis Point-of-Care test

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

Sponsors

Landstinget i Värmland
CollaboratorOTHER
Hemcheck Sweden AB
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Hemolysis frequency.Through 52 weeksCompare the volume of hemolyzed blood samples in two groups.

Countries

Sweden

Outcome results

None listed

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