Hemolysis Clinical Trial
Official title:
Open Label, Single Center Clinical Trial 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.
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.
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