NCT02976610

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,671

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 29, 2016

Completed
2 days until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2017

Completed
Last Updated

June 12, 2017

Status Verified

June 1, 2017

Enrollment Period

5 months

First QC Date

November 24, 2016

Last Update Submit

June 9, 2017

Conditions

HemolysisBlood Specimen Collection

Keywords

hemolysis

Outcome Measures

Primary Outcomes (1)

  • Hemolysis frequency.

    Compare the volume of hemolyzed blood samples in two groups.

    Through 52 weeks

Study Arms (2)

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

Hemolysis Point-of-Care testDEVICE

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

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Blood sample analysis ordered:
  • Electrolyte
  • Troponin T
  • ALAT, ASAT, ALP.

You may not qualify if:

  • Incompletely filled tubes
  • Minors (\< 18 years)
  • Patient not fit according to the health care professional assessment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emergency department, Central Hospital Karlstad

Karlstad, Värmland County, 65230, Sweden

Location

MeSH Terms

Conditions

Hemolysis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical chemist, physician.

Study Record Dates

First Submitted

November 24, 2016

First Posted

November 29, 2016

Study Start

December 1, 2016

Primary Completion

May 5, 2017

Study Completion

May 5, 2017

Last Updated

June 12, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)