CT Perfusion Imaging for Subarachnoid Hemorrhage

(CT-PIPS Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nova Scotia Health Authority

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

41 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment CT Perfusion Imaging for Subarachnoid Hemorrhage?

CT perfusion imaging can help predict delayed cerebral ischemia (a condition where the brain doesn't get enough blood) and the overall outcome in patients with subarachnoid hemorrhage, as shown in studies where it was used within 72 hours of admission. ^{1 2 3 4 5}

Is CT perfusion imaging safe for humans?

CT perfusion imaging involves exposure to radiation, which is a safety consideration. The studies mention the risks of radiation exposure, but do not provide specific safety data for humans. It's important to discuss these risks with your healthcare provider. ^{1 3 6 7 8}

How is CT Perfusion Imaging different from other treatments for subarachnoid hemorrhage?

CT Perfusion Imaging is unique because it provides a rapid and detailed assessment of blood flow in the brain, helping to detect early changes and predict complications like vasospasm and delayed cerebral ischemia, which are critical in managing subarachnoid hemorrhage. Unlike other treatments, it uses advanced imaging to guide decisions rather than directly treating the condition. ^{1 3 6 9 10}

Research Team

Gwynedd E Pickett, MD

Principal Investigator

Capital District Health Authority, Halifax, Canada

Eligibility Criteria

This trial is for individuals aged 18-75 who have had a brain hemorrhage due to a ruptured aneurysm and can consent to participate. They must be able to attend follow-up visits and not be in another study, pregnant, breastfeeding, or expected to pass away within 24 hours.

Inclusion Criteria

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 history indicates high risk of non-compliance (e.g., substance abuse, psychosocial issues, etc.)

Patient is currently breast feeding, or pregnant

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Assessment

CT perfusion imaging performed on admission to measure cerebral blood flow and other parameters

Baseline

1 visit (in-person)

Monitoring

CT perfusion imaging on day 6 post-hemorrhage to assess risk of vasospasm and delayed cerebral ischemia

6 days post-SAH

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after initial assessments, including radiation dose and delayed cerebral ischemia

30 days post-SAH

Treatment Details

Interventions

• CT Perfusion

Trial Overview The trial tests if CT perfusion scans can predict vasospasm—a dangerous narrowing of blood vessels in the brain after hemorrhage—by performing scans when patients are admitted and again on day six.

Participant Groups

Group I: CT Perfusion Experimental Treatment 1 Intervention

All patients enrolled in the study

Who Is Running the Clinical Trial?

Nova Scotia Health Authority

Lead Sponsor

Trials

302

Recruited

95,300+

Gwynedd Pickett

Lead Sponsor

Trials

1

Recruited

40+

References

1. United States pubmed.ncbi.nlm.nih.gov

Computed tomography perfusion as a predictor of delayed cerebral ischemia and functional outcome in spontaneous subarachnoid hemorrhage: A single center experience. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Usefulness of computed tomography in predicting outcome after aneurysmal subarachnoid hemorrhage: a preliminary report of the Cooperative Aneurysm Study. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Effects of Radiation Exposure on the Cost-Effectiveness of CT Angiography and Perfusion Imaging in Aneurysmal Subarachnoid Hemorrhage. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Prognostic Assessment of Aneurysmal Subarachnoid Patients with WFNS Grade V by CT Perfusion on Arrival. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

The venous delay phenomenon in computed tomography angiography: a novel imaging outcome predictor for poor cerebral perfusion after severe aneurysmal subarachnoid hemorrhage. [2019]

6. Germany pubmed.ncbi.nlm.nih.gov

Using CT perfusion during the early baseline period in aneurysmal subarachnoid hemorrhage to assess for development of vasospasm. [2021]

7. Ireland pubmed.ncbi.nlm.nih.gov

Whole-brain CT perfusion on admission predicts delayed cerebral ischemia following aneurysmal subarachnoid hemorrhage. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Early Perfusion Computed Tomography Scan for Prediction of Vasospasm and Delayed Cerebral Ischemia After Aneurysmal Subarachnoid Hemorrhage. [2020]

9. Ireland pubmed.ncbi.nlm.nih.gov

Safety and feasibility in highly concentrated contrast material power injections for CT-perfusion studies of the brain using central venous catheters. [2016]

10. Austria pubmed.ncbi.nlm.nih.gov

Acute perfusion changes after spontaneous SAH: a perfusion CT study. [2016]