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CT Perfusion Imaging to Predict Vasospasm in Subarachnoid Hemorrhage (CT-PIPS)

Primary Purpose

Subarachnoid Hemorrhage, Delayed Cerebral Ischemia, Cerebral Vasospasm

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
CT Perfusion
Sponsored by
Nova Scotia Health Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Subarachnoid Hemorrhage

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Sites / Locations

  • Halifax Infirmary, Capital District Health Authority

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CT Perfusion

Arm Description

All patients enrolled in the study

Outcomes

Primary Outcome Measures

CBF Admit
Cerebral blood flow as measured on CT perfusion study on admission
CBV Admit
Cerebral blood volume as measured on CT perfusion study on admission
MTT Admit
Mean transit time as measured on CT perfusion study on admission
TTP Admit
Time to peak as measured on CT perfusion study on admission
CBF day 6
Cerebral blood flow as measured on CT perfusion study on day 6 following subarachnoid hemorrhage
CBV day 6
Cerebral blood volume as measured on CT perfusion study on day 6 following subarachnoid hemorrhage
MTT day 6
Mean transit time as measured on CT perfusion study on day 6 following subarachnoid hemorrhage
TTP day 6
Time to peak as measured on CT perfusion study on day 6 following subarachnoid hemorrhage

Secondary Outcome Measures

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.

Full Information

First Posted
February 3, 2014
Last Updated
February 6, 2023
Sponsor
Nova Scotia Health Authority
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1. Study Identification

Unique Protocol Identification Number
NCT02056769
Brief Title
CT Perfusion Imaging to Predict Vasospasm in Subarachnoid Hemorrhage
Acronym
CT-PIPS
Official Title
CT Perfusion Imaging to Predict Vasospasm in Subarachnoid Hemorrhage
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 2014 (Actual)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nova Scotia Health Authority

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subarachnoid Hemorrhage, Delayed Cerebral Ischemia, Cerebral Vasospasm, CT Perfusion

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CT Perfusion
Arm Type
Experimental
Arm Description
All patients enrolled in the study
Intervention Type
Radiation
Intervention Name(s)
CT Perfusion
Intervention Description
Quantitative CT Perfusion imaging
Primary Outcome Measure Information:
Title
CBF Admit
Description
Cerebral blood flow as measured on CT perfusion study on admission
Time Frame
Baseline
Title
CBV Admit
Description
Cerebral blood volume as measured on CT perfusion study on admission
Time Frame
Baseline
Title
MTT Admit
Description
Mean transit time as measured on CT perfusion study on admission
Time Frame
Baseline
Title
TTP Admit
Description
Time to peak as measured on CT perfusion study on admission
Time Frame
Baseline
Title
CBF day 6
Description
Cerebral blood flow as measured on CT perfusion study on day 6 following subarachnoid hemorrhage
Time Frame
Day 6 post-SAH
Title
CBV day 6
Description
Cerebral blood volume as measured on CT perfusion study on day 6 following subarachnoid hemorrhage
Time Frame
Day 6 post-SAH
Title
MTT day 6
Description
Mean transit time as measured on CT perfusion study on day 6 following subarachnoid hemorrhage
Time Frame
Day 6 post-SAH
Title
TTP day 6
Description
Time to peak as measured on CT perfusion study on day 6 following subarachnoid hemorrhage
Time Frame
Day 6 post-SAH
Secondary Outcome Measure Information:
Title
Radiation Dose
Description
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.
Time Frame
30 days post-SAH
Other Pre-specified Outcome Measures:
Title
Delayed Cerebral Ischemia
Description
Delayed cerebral ischemia is defined using a consensus recently agreed upon by an international panel of experts: namely, 1) stroke seen on CT or MRI scan, or proven at autopsy (not including stroke related to the aneurysm treatment), or 2) clinical deterioration presumed to be caused by DCI after other causes are excluded.
Time Frame
30 days post-SAH

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gwynedd E Pickett, MD
Organizational Affiliation
Capital District Health Authority, Halifax, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Halifax Infirmary, Capital District Health Authority
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada

12. IPD Sharing Statement

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CT Perfusion Imaging to Predict Vasospasm in Subarachnoid Hemorrhage

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