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

Not Applicable

Completed

• Conditions: Hemolysis; Blood Specimen Collection
• Interventions: Device: Hemolysis Point-of-Care test

• Registration Number: NCT02976610
• Lead Sponsor: Hemcheck Sweden AB

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 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.

Study Timeline

• Study First Submitted: 2016-11-24
• Study First Submitted QC: 2016-11-24
• Study First Posted: 2016-11-29
• Study Start: 2016-12-01
• Primary Completion: 2017-05-05
• Study Completion: 2017-05-05
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-09
• Last Update Posted: 2017-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1671

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Hemolysis Point-of-Care test	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.

Primary Outcome Measures

Name	Time	Method
Hemolysis frequency.	Through 52 weeks	Compare the volume of hemolyzed blood samples in two groups.

Trial Locations

Locations (1)

Emergency department, Central Hospital Karlstad; 🇸🇪 Karlstad, Värmland, Sweden