Role of CT Perfusion in Predicting Poor Outcome After Subarachnoid Hemorrhage

September 15, 2021 updated by: Mohamed Abdel-Tawab Mohamed, Assiut University

Role of Computed Tomography Perfusion in Detection of Patients at Risk for Delayed Cerebral Ischemia After Subarachnoid Hemorrhage

Prospective evaluation of patients with subarachnoid hemorrhage (SAH) will be done by computed tomography angiography (CTA) and perfusion imaging (CTP) for any correlation between degree of vasospasm and perfusion deficit as well as evaluating the ability of CTP to predict delayed cerebral ischemia.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Cerebral vasospasm is a serious complication of subarachnoid haemorrhage . In the first 2 weeks of SAH, angiographic vasospasm is seen up to 40-70% of patients and causes ischemic deficits in 15-36% of patients.

The best clinical indicator of significantly reduced brain perfusion (cerebral blood flow (CBF)<20 ml per 100 g/min) is the presence of new neurologic deficits. However, clinical symptoms may be vague and mimic other conditions in patients with SAH.

CT Perfusion can be used in the evaluation of patients with possible vasospasm after subarachnoid hemorrhage (SAH). It can thus be used to assess cerebral ischemia and infarction as a result of vasospasm after SAH.

The presence of cerebral vasospasm identified with transcranial Doppler, digital subtraction angiography, or CT angiography (CTA) is frequently used to confirm DCI. Presence of vasospasm, however, does not prove the presence of ischemia and absence of vasospasm does not rule out. Better diagnostic tests in the acute stage of deterioration, possibly caused by DCI, are therefore needed. In patients with SAH, CTP has recently been shown to be promising for detection of early ischemia.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 71511
        • Mohamed Abdel-Tawab Mohamed

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients having subarachnoid hemorrhage whether post aneurysmal or spontaneous

Description

Inclusion Criteria:

  • All patients presented with subarachnoid haemorrhage

Exclusion Criteria:

  • Patients with abnormal renal functions with creatinine ≥ 2 mg/dl/
  • Patients with hypersensitivity to contrast media.
  • Contraindication to radiation as pregnancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Patients with poor outcome
Follow up of patients is done for 21 days by combined clinical and radiological examination. Poor clinical outcome is associated with vasospasm leading to permanent neurological deficit, stroke or death.
Patients without poor outcome
Patients who do not develop delayed cerebral ischemia or stroke, confirmed by combined clinical and radiological examination.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cerebral blood flow (CBF) on Admission
Time Frame: 3 days from the attack

Cerebral blood flow (CBF) on Admission in units of ml/100 gram brain tissue/ minute.

The measurements will be compared with the outcome of the patient (namely monitoring delayed cerebral ischemia in SAH patients) to test if early CT perfusion could predict the poor outcome in SAH patients.
3 days from the attack
Cerebral blood volume (CBV) on Admission
Time Frame: 3 days from the attack
Cerebral blood volume (CBF) on Admission in units of ml/100 gram brain tissue.
3 days from the attack
Mean transit time (MTT) on Admission
Time Frame: 3 days from the attack
Mean transit time (MTT) on Admission in units of seconds.
3 days from the attack

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Correlation of vasospasm to perfusion abnormality using Comparing between CT angiography and CT perfusion in patients with subarachnoid hemorrhage
Time Frame: 4-14 days from the attack
Evaluating results of CT angiography and CT perfusion in patients for Correlating vasospasm and perfusion abnormality. Results will be dichotomous; positive and negative, then tested by cross tabulation.
4-14 days from the attack
Hunt and Hess scale
Time Frame: 3 days from the attack

Hunt and Hess clinical scale was performed for every patient.

Grades are as the following:

Grade 1: Asymptomatic or mild headache Grade 2: Cranial nerve palsy or moderate to severe headache/nuchal rigidity Grade 3: Mild focal deficit, lethargy, or confusion Grade 4: Stupor and/or hemiparesis Grade 5: Deep coma, decerebrate posturing, moribund appearance
3 days from the attack
Fisher scale
Time Frame: 3 days from the attack

Fisher scale quantifies the amount of SAH as the following:

  1. None evident
  2. Less than 1 mm thick
  3. More than 1 mm thick
  4. Diffuse or none with intraventricular hemorrhage or parenchymal extension
3 days from the attack

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mohamed Abdel-Tawab, Assiut University
  • Study Chair: Afaf A. Hasan, Profosser, Assiut University
  • Study Director: Mohamed A. Ahmed, Professor, Assiut University
  • Study Director: Hany M. Seif, Professor, Assiut University
  • Study Director: Hazem A. Youssef, Professor, Assiut unviersity

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 29, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 11, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 16, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CTP predicts DCI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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