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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:

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.

Sponsor: Hemcheck Sweden AB

Current Primary Outcome: Hemolysis frequency. [ Time Frame: Through 52 weeks ]

Original Primary Outcome: Compare the volume of hemolyzed blood samples. [ Time Frame: Through 52 weeks ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Hemcheck Sweden AB

Dates:
Date Received: November 24, 2016
Date Started: November 2016
Date Completion: December 2017
Last Updated: December 1, 2016
Last Verified: December 2016