HAPTO study
Research type
Research Study
Full title
HAPTO study: Haemoglobin And vancomycin Pharmacokinetics in the cerebrospinal fluid following subarachnoid haemorrhage: Therapeutic Optimisation of haptoglobin
IRAS ID
339688
Contact name
Diederik Bulters
Contact email
Sponsor organisation
University Hospital Southampton
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 3 months, 31 days
Research summary
After SAH, haemoglobin – a protein found inside red blood cells – leaks out of cells into the brain and its surrounding fluid. Haemoglobin, when it leaks out, is toxic to the brain and causes damage. Our bodies’ natural defence – haptoglobin – can grab onto haemoglobin and stop its harmful effects. However, there is virtually none in the brain to protect it against haemoglobin. Therefore, haptoglobin is being developed as a drug that can be delivered directly to the brain to treat patients with SAH. Before it can be used, we need to know how much haptoglobin needs to be given and how to give it.
In this study, we will measure the amount of haemoglobin in different areas of the brain and spine after SAH: the ventricles (cavities in the brain), the lumbar spine (lower back), and the basal cisterns (near the brain's base where aneurysms are normally found). By collecting fluid samples from these places, we can measure how much haemoglobin there is, and from this, we can work out how much haptoglobin will be needed.
Apart from knowing how much to give, we need to know where to give it. The main options are to insert it either through a tube in the cavities of the brain (external ventricular drain) or a tube inserted into the spine (lumbar drain). Little is known about how drugs distribute around the nervous system in general, and even less in patients who have had an SAH in whom the flow of fluid around the brain is disturbed. This study will try to find out more by using a common antibiotic, vancomycin, as a tracer to understand how drugs move within different regions of the brain and spine following SAH. This approach will provide valuable insights into the possible ways to give haptoglobin.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
24/SC/0173
Date of REC Opinion
4 Jun 2024
REC opinion
Further Information Favourable Opinion