Tiny Scratch Study
Research type
Research Study
Full title
Comparison of Capillary and Venous Blood Sampling for blood tests for hepatitis
IRAS ID
296170
Contact name
William Rosenberg
Contact email
Sponsor organisation
The Royal Free London NHS Foundation Trust R&D
Clinicaltrials.gov Identifier
WMR17, Local Study Reference
Duration of Study in the UK
0 years, 5 months, 31 days
Research summary
Assessment of patients with Hepatitis C Virus (HCV) infection requires the identification of the HCV genotype, the virus load (VL) and the patient’s liver fibrosis status. The patient’s full blood count, kidney and liver function are assessed with simple blood tests. Each of these tests is routinely performed on venous blood samples obtained through venesection using a needle and blood bottle or a syringe.
Routine venesection may be difficult in some patients who have veins that are hard to find or access and the process of venesection requires training and skill.
A new licensed device called TapII is capable of obtaining a blood sample through the skin in 2-3 minutes using very small needles that pierce the skin painlessly. The blood is collected in a small tube and can then be used for testing. Patients can be taught to obtain their own samples that can then be sent to a laboratory for testing, removing the necessity for a qualified venesector (phlebotomist) to obtain a venous blood sample.
Consenting participants recruited from the Royal Free viral hepatitis service, undergoing investigation prior to treatment, will be asked to use the TapII device to obtain a research blood sample (about 1/2 a teaspoon full). They will then be asked to provide a routine blood sample obtained using a needle and blood collection tubes or a syringe. After each sampling they will be asked to complete a questionnaire about this experience.
Standard blood tests will be performed using the routine and research blood samples. All the tests results will be entered into a research database and anonymised. Only the results obtained from the routine sample obtained with needle will be used to determine clinical care and recorded in the patient's clinical record.REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
21/EE/0221
Date of REC Opinion
24 Aug 2021
REC opinion
Favourable Opinion