Subarachnoid HemorrhageHAPTONCT06373640
Haemoglobin And Vancomycin Pharmacokinetics in the Cerebrospinal Fluid Following Subarachnoid Haemorrhage
A study testing Insertion of drains and Vancomycin in people with Subarachnoid Hemorrhage, run by University Hospital Southampton NHS Foundation Trust.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Subarachnoid Hemorrhage
- What is being tested?
- Insertion of drains and Vancomycin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- Nov 2024to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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).
- Subject met eligibility criteria but was not needed for enrolment / randomization.
About this study
Official title: HAPTO Study: Haemoglobin And Vancomycin Pharmacokinetics in the Cerebrospinal Fluid Following Subarachnoid Haemorrhage: Therapeutic Optimisation of Haptoglobin
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.
Read the detailed description
The HAPTO study aims to improve the treatment of a specific type of stroke known as aneurysmal subarachnoid haemorrhage (aSAH). This stroke can occur when a weak point in a blood vessel in the brain called an aneurysm bursts. This causes bleeding into the surrounding area. aSAH is not only life-threatening, but also leaves many survivors with long-term disabilities and health issues that affect the quality of their life.
After aSAH, haemoglobin - a protein normally found inside red blood cells - leaks out into the brain and its surrounding fluid. While inside red blood cells, haemoglobin is safe, but when it leaks out it is toxic and causes more damage to the brain. Our bodies have a natural defence, which is a substance called haptoglobin. Haptoglobin can grab onto haemoglobin and potentially stop its harmful effects. Although there is lots of haptoglobin in the rest of the body, there is virtually none in the brain to protect against haemoglobin. Therefore, haptoglobin is being developed as a drug that can be delivered directly to the brain to treat patients with aSAH.
The HAPTO study measures the amount of haemoglobin that different areas of the brain and spine are exposed to after aSAH. These areas are 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 aSAH 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 aSAH. This approach will provide valuable insights into the possible ways to give haptoglobin (and any other future treatments requiring injection into the brain or spine).
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
- Being tested
- Insertion of drains, Vancomycin
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insertion of drainsProcedure or surgery
Also called Drain insertion
Insertion of lumbar drain and basal cistern drain
VancomycinDrug
Also called Antibiotic adminsitration
Administration of vancomycin
| Study group | Role | What they receive |
|---|---|---|
| EVD first | Other | Vancomycin to be administered first through an EVD Receives: Procedure: Insertion of drains; Drug: Vancomycin |
| Lumbar drain first | Other | Vancomycin to be administered first through a lumbar drain Receives: Procedure: Insertion of drains; Drug: Vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
CSF-haemoglobin concentration
CSF-haemoglobin concentration
Measured: 3 days to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study startNov 2024 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoid HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06373640
- Sponsor's protocol ID
- RHM NEU0458
- Acronym
- HAPTO
- Status last verified
- Apr 2024
- First submitted
- 16 Apr 2024
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HAPTO Study: Haemoglobin And Vancomycin Pharmacokinetics in the Cerebrospinal Fluid Following Subarachnoid Haemorrhage: Therapeutic Optimisation of Haptoglobin
- ClinicalTrials.gov ID
- NCT06373640
- Acronym / sponsor ID
- HAPTO / RHM NEU0458
- Conditions
- Subarachnoid Hemorrhage
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Study start
- Nov 2024 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 18 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The HAPTO study aims to improve the treatment of a specific type of stroke known as aneurysmal subarachnoid haemorrhage (aSAH). This stroke can occur when a weak point in a blood vessel in the brain called an aneurysm bursts. This causes bleeding into the surrounding area. aSAH is not only life-threatening, but also leaves many survivors with long-term disabilities and health issues that affect the quality of their life.
After aSAH, haemoglobin - a protein normally found inside red blood cells - leaks out into the brain and its surrounding fluid. While inside red blood cells, haemoglobin is safe, but when it leaks out it is toxic and causes more damage to the brain. Our bodies have a natural defence, which is a substance called haptoglobin. Haptoglobin can grab onto haemoglobin and potentially stop its harmful effects. Although there is lots of haptoglobin in the rest of the body, there is virtually none in the brain to protect against haemoglobin. Therefore, haptoglobin is being developed as a drug that can be delivered directly to the brain to treat patients with aSAH.
The HAPTO study measures the amount of haemoglobin that different areas of the brain and spine are exposed to after aSAH. These areas are 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 aSAH 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 aSAH. This approach will provide valuable insights into the possible ways to give haptoglobin (and any other future treatments requiring injection into the brain or spine).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EVD first | Other | Procedure: Insertion of drains, Drug: VancomycinVancomycin to be administered first through an EVD |
| Lumbar drain first | Other | Procedure: Insertion of drains, Drug: VancomycinVancomycin to be administered first through a lumbar drain |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insertion of drainsAlso: Drain insertionInsertion of lumbar drain and basal cistern drain | Procedure or surgery | EVD first, Lumbar drain first |
| VancomycinAlso: Antibiotic adminsitrationAdministration of vancomycin | Drug | EVD first, Lumbar drain first |
Primary outcome
CSF-haemoglobin concentration
Time frame: 3 days to 10 days
CSF-haemoglobin concentration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Insertion of drains and Vancomycin in people with Subarachnoid Hemorrhage, run by University Hospital Southampton NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CSF-haemoglobin concentration (time frame: 3 days to 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024.