NCT02976610

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,671 (actual)
• Sponsor: Hemcheck Sweden AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hemolysis
• Blood Specimen Collection

Interventions

Type	Name	Description
DEVICE	Hemolysis Point-of-Care test	Hemolysis measurement of plasma using a point of care test to determine the hemolysis level in plasma

Timeline

• Start date: 2016-12-01
• Primary completion: 2017-05-05
• Completion: 2017-05-05
• First posted: 2016-11-29
• Last updated: 2017-06-12

Locations

1 site across 1 country: Sweden