Haemoglobin And Vancomycin Pharmacokinetics in the Cerebrospinal Fluid Following Subarachnoid Haemorrhage

NCT06373640 | Not Yet Recruiting

• 1 other identifier: RHM NEU0458
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Subarachnoid Hemorrhage

Outcome Measures

Primary Outcomes (1)

• CSF-haemoglobin concentration

  CSF-haemoglobin concentration

  3 days to 10 days

Study Arms (2)

EVD first

OTHER

Vancomycin to be administered first through an EVD

Procedure: Insertion of drains; Drug: Vancomycin

Lumbar drain first

OTHER

Vancomycin to be administered first through a lumbar drain

Procedure: Insertion of drains; Drug: Vancomycin

Interventions

Insertion of drains PROCEDURE

Insertion of lumbar drain and basal cistern drain

Also known as: Drain insertion

EVD first; Lumbar drain first

Vancomycin DRUG

Administration of vancomycin

Also known as: Antibiotic adminsitration

EVD first; Lumbar drain first

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• CT scan completed after aneurysm repair to confirm EVD position and exclude major post-repair complications
• Aged 18 years to 80 years (inclusive) at the time of providing written informed consent.
• Capable of providing written (or electronic) informed consent and willing and able to adhere to all protocol requirements or informed consent provided by the subject's legally authorized representative if the subject lacks capacity at the time of screening.
• Haemodynamically stable after resuscitation, with systolic blood pressure ≥ 90 mm Hg at screening

You may not qualify if:

• 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
• Bleeding disorder
• Decompressive hemicraniectomy at screening
• Contraindications to vancomycin: known hypersensitivity to vancomycin or teicoplanin, documented history of hearing impairment, wearing a hearing aid, or renal insufficiency (estimated glomerular filtration rate \<60 ml/min/1.73m2)
• Pregnant, planning to become pregnant, or breastfeeding
• Underwent prophylactic hypertension or balloon angioplasty between admission to hospital for aSAH and screening
• Given therapeutic magnesium infusion, and other intrathecal or intraventricular vasodilators or thrombolytics between admission to hospital for aSAH and screening
• Given IV or intrathecal / intraventricular nicardipine between admission to hospital for aSAH and screening
• Given antifibrinolytics (e.g., tranexamic acid) or intrathecal thrombolytics between admission to hospital for aSAH and screening
• Current participation in an interventional clinical study
• Direct involvement in the planning and / or conduct of this study (e.g., Sponsor employees, study site staff, as well as their immediate family members \[i.e., spouse, parent, child, or sibling, whether biological or legally adopted\]).
• Any medical condition or other issue that, in the opinion of the Investigator and / or Sponsor, would render the subject unsuitable for participation in the study (ie, issue may compromise subject safety or compliance, impede study conduct, or interfere with interpretation of study results).

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Interventions

Vancomycin

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 18, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share