CT Perfusion Imaging to Predict Vasospasm in Subarachnoid Hemorrhage

NCT02056769 | Active Not Recruiting

• 1 other identifier: CT-PIPS
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Subarachnoid Hemorrhage; Delayed Cerebral Ischemia; Cerebral Vasospasm; CT Perfusion

Outcome Measures

Primary Outcomes (8)

• CBF Admit

  Cerebral blood flow as measured on CT perfusion study on admission

  Baseline

• CBV Admit

  Cerebral blood volume as measured on CT perfusion study on admission

  Baseline

• MTT Admit

  Mean transit time as measured on CT perfusion study on admission

  Baseline

• TTP Admit

  Time to peak as measured on CT perfusion study on admission

  Baseline

• CBF day 6

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

  Day 6 post-SAH

• CBV day 6

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

  Day 6 post-SAH

• MTT day 6

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

  Day 6 post-SAH

• TTP day 6

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

  Day 6 post-SAH

Secondary Outcomes (1)

• Radiation Dose

  30 days post-SAH

Other Outcomes (1)

• Delayed Cerebral Ischemia

  30 days post-SAH

Study Arms (1)

CT Perfusion

EXPERIMENTAL

All patients enrolled in the study

Radiation: CT Perfusion

Interventions

CT Perfusion RADIATION

Quantitative CT Perfusion imaging

CT Perfusion

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (1)

Halifax Infirmary, Capital District Health Authority

Halifax, Nova Scotia, B3H 3A7, Canada

Location

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Vasospasm, Intracranial

Interventions

Cytidine Triphosphate

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)

Cytosine Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• Gwynedd E Pickett, MD

  Capital District Health Authority, Halifax, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2014
• First Posted: February 6, 2014
• Study Start: April 1, 2014
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 21, 2024

Record last verified: 2024-08

Locations

CA (1)