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

2016-11-30 15:45:23 | BioPortfolio

Summary

This study aims to investigate the outcome of hemolysis frequency when a hemolysis point of care test is introduced in a 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 a novel method for hemolysis point of care detection (H-POCT) is evaluated. The singel ues test is attached to the blood sample in direct conjuction 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. Then randomized into one of two groups. All healthcare professionals participating in this study have attended in a standard education program in operating H-POCT and information regarding the study.

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 at the emergency department in Central hospital in Karlstad.

The hospital is a county hospital with 430 beds and the emergency department treats 59000 patients yearly.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Conditions

Hemolysis

Intervention

Hemolysis Point-of-Care test

Location

Emergency department, Central Hospital Karlstad
Karlstad
Värmland
Sweden
65230

Status

Enrolling by invitation

Source

Hemcheck Sweden AB

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-11-30T15:45:23-0500

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Medical and Biotech [MESH] Definitions

Exotoxins produced by certain strains of streptococci, particularly those of group A (STREPTOCOCCUS PYOGENES), that cause HEMOLYSIS.

The destruction of ERYTHROCYTES by many different causal agents such as antibodies, bacteria, chemicals, temperature, and changes in tonicity.

The semi-permeable outer structure of a red blood cell. It is known as a red cell 'ghost' after HEMOLYSIS.

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