Hemolysis Clinical Trial
Official title:
Investigation Into the Effect of in Vitro Haemolysis on Serum High Sensitivity Troponin T Measurement, and the Determination of an Acceptable Haemolysis Index Limit
Verified date | February 2018 |
Source | Poole Hospital NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 61 |
Est. completion date | December 6, 2017 |
Est. primary completion date | December 6, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Adult patients attending Poole emergency department having High Sensitivity Troponin T measurements performed on their blood as part of their medical investigations. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Poole Hospital NHSFT | Poole | Dorset |
Lead Sponsor | Collaborator |
---|---|
Poole Hospital NHS Foundation Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The difference in measured hs-cTnT between baseline and the haemolysis groups. | Day one | ||
Secondary | The Percentage change in hs-cTnT due to haemolysis at five groups of different troponin T levels. | Day one |
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