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

NCT ID: NCT02976610

Last Updated: 2017-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1671 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-01
• Study Completion Date: 2017-05-05

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.

Conditions

Hemolysis; Blood Specimen Collection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

1

This is the control group where no intervention takes place. Blood sampling carried out according to routine at the emergency department.

Group Type: NO_INTERVENTION

No interventions assigned to this group

2

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.

Group Type: EXPERIMENTAL

Hemolysis Point-of-Care test

Intervention Type: DEVICE

Hemolysis measurement of plasma using a point of care test to determine the hemolysis level in plasma

Interventions

Hemolysis Point-of-Care test

Hemolysis measurement of plasma using a point of care test to determine the hemolysis level in plasma

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Landstinget i Värmland

OTHER

Sponsor Role: collaborator

Hemcheck Sweden AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Lars-Olof Hansson

Clinical chemist, physician.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lars O Hansson, MD-PhD

Role: STUDY_CHAIR

Landstinget i Värmland

Anders Hallberg, MD-PhD

Role: STUDY_CHAIR

Centrum för klinisk forskning, SCK, Älvgatan 49, 651 85 Karlstad

Locations

Emergency department, Central Hospital Karlstad

Karlstad, Värmland County, Sweden

Countries

Sweden

Other Identifiers

HC001

Identifier Type: -

Identifier Source: org_study_id