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

Hemolysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02976610
• Other study ID #: HC001
• 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
• 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

Related Conditions & MeSH terms

• Blood Specimen Collection
• Emergencies
• Hemolysis

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