Haemoglobin And Vancomycin Pharmacokinetics in the Cerebrospinal Fluid Following Subarachnoid Haemorrhage

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity Hospital Southampton NHS Foundation Trust

About this trial

The HAPTO study will recruit adult patients with aSAH due to a burst aneurysm. These patients must be scheduled to have their aneurysm treated surgically to prevent further bleeds, and need an external ventricular drain for clinical reasons (to drain fluid and relieve pressure on the brain). At the end of their surgery for their aneurysm, a further drain will be left at the site of the surgery (which is in the basal cisterns) and they will additionally have a drain sited in their lumbar spine. Vancomycin will be given through these drains. Additionally, these drains will allow the fluid in the brain to be collected to measure how haemoglobin levels and vancomycin levels differ between compartments and change over time. Patients will participate in the study over a period from recruitment at three days after aSAH to a maximum of ten days after aSAH. The data will be analysed to determine the relationship in haemoglobin concentrations between different areas of the brain and spine after aSAH, and how vancomycin distribution is related to its route of administration.

Eligibility criteria

Qualifiers

aSAH on pre-repair CT scan graded 2, 3, or 4 on Modified Fisher Scale (diffuse [clot present in both hemispheres] thick or thin, or local thick).

Ruptured saccular aneurysm confirmed by angiography (CT angiogram, MR angiogram, or digital subtraction angiography)

EVD in situ in the lateral ventricle (or anticipated to have an EVD inserted)

Scheduled for surgery to clip the aneurysm (or has had surgery to clip the aneurysm with a proximal Sylvian fissure/basal cistern drain left in situ)

Disqualifiers

SAH due to giant aneurysm (i.e., size ≥ 2.5 cm) or causes other than a saccular aneurysm (e.g., rupture of infective aneurysm, traumatic head injury / traumatic SAH).

Bilateral blown pupils

Isolated intraventricular haemorrhage or intracerebral haemorrhage without SAH

aSAH diagnosed on LP with no evidence of blood on CT

Trial design

Treatments tested in this trial

  • Insertion of drains
  • Vancomycin

Treatment groups

14 Participants
are divided into 2 treatment groups

Locations

This trial has no locations