Effect of in Vitro Haemolysis on Serum High Sensitivity Troponin T Measurements From Patients in Accident & Emergency

NCT03439605 | Completed

• 1 other identifier: SP170327
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be investigating how a common blood test for identifying heart damage (Troponin T) is affected by red blood cell damage in the blood sample (Haemolysis). It is already known that damage to the red blood cells during or after blood sample collection can cause falsely low test results however the exact amount is not clear. Some previous studies suggest that a much higher amount of red blood cell damage could be allowable when reporting the test results. This study will mimic the type of red blood cell damage that occurs in the hospital and determine what degree of damage or 'haemolysis' causes a significant reduction in the test result and therefore determine an allowable limit for safely reporting the test result. The results of this study may help provide an evidence based approach to improving current practice and may lead to fewer rejected blood samples, fewer repeat tests, improved A\&E treatment times, general cost savings and an improved service to patients.

Conditions

Troponin T; Hemolysis

Keywords

Troponin-T; Haemolysis

Outcome Measures

Primary Outcomes (1)

• The difference in measured hs-cTnT between baseline and the haemolysis groups.

  Day one

Secondary Outcomes (1)

• The Percentage change in hs-cTnT due to haemolysis at five groups of different troponin T levels.

  Day one

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients attending Poole emergency department having High Sensitivity Troponin T measurements performed on their blood as part of their medical investigations.

You may qualify if:

• Adult patients attending Poole emergency department having High Sensitivity Troponin T measurements performed on their blood as part of their medical investigations.

You may not qualify if:

• Serum samples with Haemolysis Index \>20.
• Serum High sensitivity Troponin T result \<5 ng/l and \>100 ng/l
• Patients lacking capacity to give verbal consent.
• Under 18 years of age.
• Patient has previously been approached about this study.

Sponsors & Collaborators

• Poole Hospital NHS Foundation Trust: lead

Study Sites (1)

Poole Hospital NHSFT

Poole, Dorset, BH15 2JB, United Kingdom

Location

MeSH Terms

Conditions

Hemolysis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2018
• First Posted: February 20, 2018
• Study Start: September 9, 2017
• Primary Completion: December 6, 2017
• Study Completion: December 6, 2017
• Last Updated: February 20, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)