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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02976610
Other study ID # HC001
Secondary ID
Status Completed
Phase N/A
First received November 24, 2016
Last updated June 9, 2017
Start date December 1, 2016
Est. completion date May 5, 2017

Study information

Verified date June 2017
Source Hemcheck Sweden AB
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 1671
Est. completion date May 5, 2017
Est. primary completion date May 5, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Hemolysis Point-of-Care test
Hemolysis measurement of plasma using a point of care test to determine the hemolysis level in plasma

Locations

Country Name City State
Sweden Emergency department, Central Hospital Karlstad Karlstad Värmland

Sponsors (2)

Lead Sponsor Collaborator
Hemcheck Sweden AB Landstinget i Värmland

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hemolysis frequency. Compare the volume of hemolyzed blood samples in two groups. Through 52 weeks
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