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Special Imaging Technique to Aid in the Diagnosis of Patients in Coma After Cardiac Arrest

Primary Purpose

Brain Death

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Computed tomography perfusion
Sponsored by
Nova Scotia Health Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Brain Death focused on measuring Computed tomography, Perfusion imaging, Coma, Heart arrest, Brain death

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All adult patients (age range: 18-80 years), in a coma for at least 24 hours following cardiac arrest who are admitted to our cardiac intensive care unit and who have recovered body temperature back to normal after being subjected to the therapeutic hypothermia protocol will be included in the study.
  • Also included are those patients whose next of kin have provided consent for the study.

Exclusion Criteria:

  • patients who are pregnant,
  • those with impaired renal function,
  • those who have contraindications to the CT contrast media (such as a known allergy or anaphylactic reactions) and
  • those who do not provide consent. Pregnant patients will be excluded to avoid any potential adverse effect of radiation from CT perfusion study on the developing foetus. A developing foetus is more vulnerable to radiation when compared to adult patients.

Patients above 80 years will be excluded to avoid age related comorbidities affecting the patients' survival.

We do not see patients below 18 years of age at our institution thus they will be excluded.

Sites / Locations

  • Queen Elizabeth II Health Sciences Centre-Halifax InfirmaryRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Computed tomography perfusion

Arm Description

Participants will undergo CT perfusion of the head after cooling following cardiac arrest.

Outcomes

Primary Outcome Measures

Clinical evaluation of brainstem function
Clinical evaluation of brainstem function at the end of hospital stay.

Secondary Outcome Measures

Number of adverse events as a measure of safety and tolerability

Full Information

First Posted
March 28, 2014
Last Updated
April 21, 2016
Sponsor
Nova Scotia Health Authority
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1. Study Identification

Unique Protocol Identification Number
NCT02102945
Brief Title
Special Imaging Technique to Aid in the Diagnosis of Patients in Coma After Cardiac Arrest
Official Title
CT Perfusion in the Prognostication of Patients in Coma Following Cardiac Arrest- A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
In the present pilot study, the investigators propose to determine if performing CT perfusion scans in post-cardiac arrest patients in coma will help prognosticate the outcome in these patients.
Detailed Description
Cardiac arrest is common and is associated with poor survival despite intensive medical care. These patients are subjected to cooling therapy to improve neurological outcomes. After cooling these patients are allowed to spontaneously return to normal body temperature. From here on, the outcome of these patients is mainly dependent on a wait and watch approach as the clinical examination of patients in a coma is very limited. Despite these attempts, 41% of these patients die and only 55 % of them have a favourable neurological outcome. There have been few clinical scoring systems to provide prognosis in the face of a cardiac arrest but none of them address the more serious group- those in coma. For patients in coma, their medications, particularly those that suppress the central nervous system, cause difficulty in their clinical assessment. Multiple ancillary tests, such as routine CT or MRI of brain, do not give any useful prognostic information. We hypothesize that the neurological outcome of patients in coma is mainly dependent on presence of brainstem function. To the best of our knowledge, no study has addressed the issue of brainstem function in cardiac arrest patients. This may be due to the fact that there was no imaging tool which could confidently depict the function of the brainstem. In a recently performed study in our institution, using CT perfusion technique, we have demonstrated that patients with diffusely impaired brainstem perfusion have poor prognosis and do not survive. This study is already being considered by the World Health Organization for the modification of criteria for the declaration of brain death. We suggest that a similar imaging technique will potentially be useful in prognosticating patients in coma following cardiac arrest. In the present pilot study, we propose to determine if performing CT perfusion scans in post-cardiac arrest patients in coma will help prognosticate the outcome in these patients. This may potentially help in early withdrawal of care in patients with significantly impaired brainstem function. If so, this will have a significant impact on patient care and can potentially have huge financial implications for the health care system. Such early decision making may also help in organ harvesting in suitable situations. This will potentially improve the quality of life in many other terminally ill patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Death
Keywords
Computed tomography, Perfusion imaging, Coma, Heart arrest, Brain death

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Computed tomography perfusion
Arm Type
Other
Arm Description
Participants will undergo CT perfusion of the head after cooling following cardiac arrest.
Intervention Type
Procedure
Intervention Name(s)
Computed tomography perfusion
Intervention Description
Computed tomography perfusion of the head
Primary Outcome Measure Information:
Title
Clinical evaluation of brainstem function
Description
Clinical evaluation of brainstem function at the end of hospital stay.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Number of adverse events as a measure of safety and tolerability
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All adult patients (age range: 18-80 years), in a coma for at least 24 hours following cardiac arrest who are admitted to our cardiac intensive care unit and who have recovered body temperature back to normal after being subjected to the therapeutic hypothermia protocol will be included in the study. Also included are those patients whose next of kin have provided consent for the study. Exclusion Criteria: patients who are pregnant, those with impaired renal function, those who have contraindications to the CT contrast media (such as a known allergy or anaphylactic reactions) and those who do not provide consent. Pregnant patients will be excluded to avoid any potential adverse effect of radiation from CT perfusion study on the developing foetus. A developing foetus is more vulnerable to radiation when compared to adult patients. Patients above 80 years will be excluded to avoid age related comorbidities affecting the patients' survival. We do not see patients below 18 years of age at our institution thus they will be excluded.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jai JS Shankar, MD, DM
Phone
9027435448
Email
JaiJai.Shankar@cdha.nshealth.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jai JS Shankar, MD, DM
Organizational Affiliation
Queen Elizabeth II Health Sciences Centre, Halifax Infirmary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Elizabeth II Health Sciences Centre-Halifax Infirmary
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jai Shankar, MD
Phone
902-473-5448
Email
shivajai1@gmail.com
First Name & Middle Initial & Last Name & Degree
Jai JS Shankar, MD, DM

12. IPD Sharing Statement

Plan to Share IPD
No

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Special Imaging Technique to Aid in the Diagnosis of Patients in Coma After Cardiac Arrest

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