Clinical trial NCT02976610: Clinical Study of a Novel Hemolysis Point of Care Test at an Emergency Department.
Official title: Open Label, Single Center Clinical Trial of a Novel Hemolysis Point of Care Test at an Emergency Department.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemolysis
Blood Specimen Collection
Keywords: hemolysis
Lead sponsor: Hemcheck Sweden AB
Sponsor class: INDUSTRY
Collaborators: name: Landstinget i Värmland
First posted: 2016-11-29
Enrollment: 1671
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Hemolysis frequency.
timeFrame: Through 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Karlstad
country: Sweden
facility: Emergency department, Central Hospital Karlstad
state: Värmland
Study officials:
affiliation: Landstinget i Värmland
name: Lars O Hansson, MD-PhD
role: STUDY_CHAIR
affiliation: Centrum för klinisk forskning, SCK, Älvgatan 49, 651 85 Karlstad
name: Anders Hallberg, MD-PhD
role: STUDY_CHAIR
References: