Clinical Study of a Novel Hemolysis Point of Care Test at... | NCT02976610

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

NCT02976610

Sponsor

Hemcheck Sweden AB

Status

Completed

Last Update Posted

Jun 12, 2017Actual

Enrollment

1,671Actual

Phase

Not Applicable

Conditions

Hemolysis
Blood Specimen Collection

Interventions

Hemolysis Point-of-Care test

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2016Actual

Primary Completion Date

May 5, 2017Actual

Completion Date

May 5, 2017Actual

First Submitted Date

Nov 24, 2016

First Submission Date that Met QC Criteria

Nov 24, 2016

First Posted Date

Nov 29, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 9, 2017

Last Update Posted Date

Jun 12, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lars-Olof Hansson, Clinical chemist, physician., Landstinget i VärmlandPrincipal Investigator

Lead Sponsor

Hemcheck Sweden ABINDUSTRY

Collaborators

Name	Class
Landstinget i Värmland	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,671Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	No Intervention	This is the control group where no intervention takes place. Blood sampling carried out according to routine at the emergency department.
2	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hemolysis Point-of-Care test	Device	Hemolysis measurement of plasma using a point of care test to determine the hemolysis level in plasma	2

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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 Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Emergency department, Central Hospital Karlstad		Karlstad	Värmland County	65230	Sweden

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006461	Hemolysis

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

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Browse Branches

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