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

Primary Purpose

Hemolysis, Blood Specimen Collection

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Hemolysis Point-of-Care test
Sponsored by
Hemcheck Sweden AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hemolysis focused on measuring hemolysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Emergency department, Central Hospital Karlstad

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

1

2

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Hemolysis frequency.
Compare the volume of hemolyzed blood samples in two groups.

Secondary Outcome Measures

Full Information

First Posted
November 24, 2016
Last Updated
June 9, 2017
Sponsor
Hemcheck Sweden AB
Collaborators
Landstinget i Värmland
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1. Study Identification

Unique Protocol Identification Number
NCT02976610
Brief Title
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

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
December 1, 2016 (Actual)
Primary Completion Date
May 5, 2017 (Actual)
Study Completion Date
May 5, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hemcheck Sweden AB
Collaborators
Landstinget i Värmland

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemolysis, Blood Specimen Collection
Keywords
hemolysis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1671 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
No Intervention
Arm Description
This is the control group where no intervention takes place. Blood sampling carried out according to routine at the emergency department.
Arm Title
2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Hemolysis Point-of-Care test
Intervention Description
Hemolysis measurement of plasma using a point of care test to determine the hemolysis level in plasma
Primary Outcome Measure Information:
Title
Hemolysis frequency.
Description
Compare the volume of hemolyzed blood samples in two groups.
Time Frame
Through 52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars O Hansson, MD-PhD
Organizational Affiliation
Landstinget i Värmland
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Anders Hallberg, MD-PhD
Organizational Affiliation
Centrum för klinisk forskning, SCK, Älvgatan 49, 651 85 Karlstad
Official's Role
Study Chair
Facility Information:
Facility Name
Emergency department, Central Hospital Karlstad
City
Karlstad
State/Province
Värmland
ZIP/Postal Code
65230
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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