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Subarachnoid HemorrhageCT-PIPSNCT02056769

CT Perfusion Imaging to Predict Vasospasm in Subarachnoid Hemorrhage

A study testing CT Perfusion in people with Subarachnoid Hemorrhage and Delayed Cerebral Ischemia, run by Nova Scotia Health Authority at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Patients with brain hemorrhage resulting from a ruptured aneurysm (SAH) are at risk of developing a condition called vasospasm, one or two weeks after their hemorrhage. This is a major cause of stroke and death following SAH. A special type of CT scan, called CT perfusion, analyzes regional blood flow in the brain. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
CT Perfusion
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
1 siteCanada
Study dates
Apr 2014to Jun 2026
Phase
Interventional
Are there results?
None posted in the registry

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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient is between 18 and 75 years of age (inclusive).
  • Patient has a documented aneurysmal SAH.
  • Patient or next of kin or person with appropriate power of attorney has provided written informed consent.
  • Patient is willing and available for study follow-up visits.
  • Patient has not been previously entered into this study.

Who cannot join

  • Inability to obtain informed written consent.
  • Patient is < 18 or > 75 years old.
  • Patient is not expected to survive >24 hours (e.g. those presenting with loss of brain stem reflexes, or patients transferred to the Halifax Infirmary ICU for consideration of organ donation rather than active treatment)
  • Patient history indicates high risk of non-compliance (e.g., substance abuse, psychosocial issues, etc.)
  • Patient is currently breast feeding, or pregnant
  • Patient is currently enrolled in another clinical study (device or drug).

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Halifax Infirmary, Capital District Health Authority

    Halifax, Nova Scotia, B3H 3A7

Other trials in Canada

About this study

Patients with brain hemorrhage resulting from a ruptured aneurysm (SAH) are at risk of developing a condition called vasospasm, one or two weeks after their hemorrhage. This is a major cause of stroke and death following SAH. A special type of CT scan, called CT perfusion, analyzes regional blood flow in the brain. We hypothesize that CT perfusion scans performed on admission and day 6 post-hemorrhage will enable us to predict which patients will go on to develop vasospasm.

Read the detailed description

Rupture of a brain aneurysm results in a type of bleeding into the brain called subarachnoid hemorrhage (SAH). This is a substantial cause of morbidity and mortality world-wide: even with the best possible care, up to half of patients die and many are left disabled. Sometimes this is because the immediate brain damage from the bleed is very severe. However, many patients who seem to be doing well at first go on to develop something called "vasospasm": narrowing of large arteries in the brain. This results in the brain not getting enough blood, and the patient can suffer a stroke as a result. The lack of blood to the brain is called delayed cerebral ischemia (DCI), and is the major secondary cause of stroke and death in patients who survived the initial aneurysm rupture.

Vasospasm can be seen on angiograms (blood vessel imaging) in about two-thirds of SAH patients, and causes neurological symptoms of DCI in half of those patients. It usually develops about a week or so after SAH. Early diagnosis and treatment of cerebral vasospasm and delayed cerebral ischemia (DCI) reduces morbidity and mortality in SAH patients.

CT perfusion imaging is able to identify areas of reduced cerebral blood flow that are at risk of DCI and stroke. This technique is able to measure cerebral blood flow and blood volume (CBF, CBV), and calculates two other measures of cerebral perfusion: time to peak intensity (TTP) and mean transit time (MTT). Taken together, these provide information about the amount of blood the brain is receiving and whether the brain is compensating for any reduction in flow. This is helpful because seeing vasospasm on imaging is not enough to predict brain ischemia and stroke; the additional physiological information provided by the perfusion assessment strengthens the diagnosis of DCI. Early evidence suggests that CT perfusion is a fast, accurate, inexpensive and non-invasive method of brain imaging to identify patients with DCI after SAH, and guide appropriate therapy.

If we were able to successfully predict which patients are at high risk of DCI and/or stroke, we could intervene early. This could improve patient outcomes, while potentially allowing better use of limited intensive care and nursing resources. Other studies have shown that patients with DCI had altered perfusion prior to developing clinical symptoms, but we do not know whether we can use CT perfusion to predict patients at risk, or which CT perfusion measurements (e.g., CBF or TTP) are most useful.

The radiation risk associated with CT perfusion imaging is negligible, due to advances in CT technology which allow for routine simultaneous CT perfusion and CT angiogram (CTA) without a significant increase in radiation dose over conventional head CT-CTA alone. Judicious use of CT perfusion, through a structured algorithm that includes routine perfusion scans at admission and during the peak risk period for vasospasm, may actually decrease cumulative radiation dose for patients with SAH, by ruling out perfusion deficit and brain ischemia as a cause of decreased neurological function and limiting repeated angiograms.

Being tested
CT Perfusion
Medical subject headings
Subarachnoid Hemorrhage, Vasospasm, Intracranial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CT PerfusionRadiation

    Quantitative CT Perfusion imaging

Study groups in NCT02056769
Study groupRoleWhat they receive
CT PerfusionExperimentalAll patients enrolled in the study
Receives: Radiation: CT Perfusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CBF Admit

    Cerebral blood flow as measured on CT perfusion study on admission

    Measured: Baseline

  2. CBV Admit

    Cerebral blood volume as measured on CT perfusion study on admission

    Measured: Baseline

  3. MTT Admit

    Mean transit time as measured on CT perfusion study on admission

    Measured: Baseline

  4. TTP Admit

    Time to peak as measured on CT perfusion study on admission

    Measured: Baseline

  5. CBF day 6

    Cerebral blood flow as measured on CT perfusion study on day 6 following subarachnoid hemorrhage

    Measured: Day 6 post-SAH

  6. CBV day 6

    Cerebral blood volume as measured on CT perfusion study on day 6 following subarachnoid hemorrhage

    Measured: Day 6 post-SAH

  7. MTT day 6

    Mean transit time as measured on CT perfusion study on day 6 following subarachnoid hemorrhage

    Measured: Day 6 post-SAH

  8. TTP day 6

    Time to peak as measured on CT perfusion study on day 6 following subarachnoid hemorrhage

    Measured: Day 6 post-SAH

Secondary outcomes (1)
  1. Radiation Dose

    Total cumulative radiation dose from cranial imaging (CT Head, CT angiogram, CT perfusion, catheter angiography, endovascular coiling) during the initial hospital admission for SAH, up to 30 days post-SAH.

    Measured: 30 days post-SAH

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2014 (estimated)
  2. Study startApr 2014
  3. Primary completionJun 2026 (estimated)
  4. Study completionJun 2026 (estimated)

Resources

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
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02056769
Sponsor's protocol ID
CT-PIPS
Acronym
CT-PIPS
Status last verified
Aug 2024
First submitted
3 Feb 2014
Last updated
21 Aug 2024
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing CT Perfusion in people with Subarachnoid Hemorrhage and Delayed Cerebral Ischemia, run by Nova Scotia Health Authority at 1 site in Canada.

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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Results are not available in the source record.

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?

CBF Admit (time frame: Baseline). The study lists 8 primary outcomes in all. 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 21 Aug 2024.

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