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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02976610
• Date of registration: 24/11/2016
• Prospective Registration: Yes
• Primary sponsor: Hemcheck Sweden AB
• Public title: Clinical Study of a Novel Hemolysis Point of Care Test at an Emergency Department.
• Scientific title: Open Label, Single Center Clinical Trial of a Novel Hemolysis Point of Care Test at an Emergency Department.
• Date of first enrolment: December 1, 2016
• Target sample size: 1671
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02976610
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Sweden

Contacts

• Name: Anders Hallberg, MD-PhD
• Affiliation: Centrum fo¨r klinisk forskning, SCK, A¨lvgatan 49, 651 85 Karlstad

• Name: Lars O Hansson, MD-PhD
• Affiliation: Landstinget i Värmland

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Blood Specimen Collection

Hemolysis

Intervention(s)

Device: Hemolysis Point-of-Care test

Primary Outcome(s)

Hemolysis frequency. [Time Frame: Through 52 weeks]

Secondary ID(s)

HC001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Landstinget i Värmland