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

Completed

Conditions

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

Observational

Enrollment (Actual)

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

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
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

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

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

Assiut University

Investigators

  • 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)

March 1, 2016

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

February 28, 2018

Study Registration Dates

First Submitted

June 29, 2017

First Submitted That Met QC Criteria

July 8, 2017

First Posted (Actual)

July 11, 2017

Study Record Updates

Last Update Posted (Actual)

September 16, 2021

Last Update Submitted That Met QC Criteria

September 15, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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