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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hemolysis, Blood Specimen Collection

Intervention / Treatment
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* Device: Hemolysis Point-of-Care test


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>This is the control group where no intervention takes place. Blood sampling carried out according to routine at the emergency department. | |
| Experimental: 2<br>During the blood sampling the health care professional will screen all vacuum Lithium Heparin tubes, with the Hemolysis point-of-care test (H-POCT). If the health care professional receives a negative test the bloodsample is sent to the local laboratory. If H-POCT indicates a positive test, of free hemoglobin in plasma, the bloodsample and H-POCT will be discarded and a new sample will be collected and screened for hemolysis. This can be repeated 3 times. | Device: Hemolysis Point-of-Care test<br>* Hemolysis measurement of plasma using a point of care test to determine the hemolysis level in plasma<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemolysis frequency. | Compare the volume of hemolyzed blood samples in two groups. | Through 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemolysis