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.

This study aims to investigate the outcome of hemolysis frequency when a hemolysis point of care test is introduced in an emergency department.

Study Overview

• Status: Completed
• Conditions: Hemolysis; Blood Specimen Collection
• Intervention / Treatment: Device: Hemolysis Point-of-Care test

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 Type: Interventional
• Enrollment (Actual): 1671
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Värmland
    • Karlstad, Värmland, Sweden, 65230
      • Emergency department, Central Hospital Karlstad

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 1; This is the control group where no intervention takes place. Blood sampling carried out according to routine at the emergency department.
Experimental: 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.	Device: Hemolysis Point-of-Care test; Hemolysis measurement of plasma using a point of care test to determine the hemolysis level in plasma

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemolysis frequency.	Compare the volume of hemolyzed blood samples in two groups.	Through 52 weeks

Collaborators and Investigators

• Sponsor: Hemcheck Sweden AB
• Collaborators: Landstinget i Värmland
• Investigators: Study Chair: Lars O Hansson, MD-PhD, Landstinget i Värmland; Study Chair: Anders Hallberg, MD-PhD, Centrum för klinisk forskning, SCK, Älvgatan 49, 651 85 Karlstad

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): May 5, 2017
• Study Completion (Actual): May 5, 2017

Study Registration Dates

• First Submitted: November 24, 2016
• First Submitted That Met QC Criteria: November 24, 2016
• First Posted (Estimate): November 29, 2016

Study Record Updates

• Last Update Posted (Actual): June 12, 2017
• Last Update Submitted That Met QC Criteria: June 9, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: hemolysis
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies; Hemolysis
• Other Study ID Numbers: HC001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No