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Trial record 60 of 194 for:    Hemorrhage AND SAH

Role of CT Perfusion in Predicting Poor Outcome After Subarachnoid Hemorrhage

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ClinicalTrials.gov Identifier: NCT03214705
Recruitment Status : Completed
First Posted : July 11, 2017
Last Update Posted : September 6, 2018
Sponsor:
Information provided by (Responsible Party):
Mohamed Abdel-Tawab Mohamed, Assiut University

Brief Summary:
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.

Condition or disease
Subarachnoid Hemorrhage Cerebral Vasospasm Delayed Cerebral Ischemia

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.


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Study Type : Observational [Patient Registry]
Actual Enrollment : 64 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 21 Days
Official Title: Role of Computed Tomography Perfusion in Detection of Patients at Risk for Delayed Cerebral Ischemia After Subarachnoid Hemorrhage
Actual Study Start Date : March 1, 2016
Actual Primary Completion Date : February 1, 2018
Actual Study Completion Date : February 28, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

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.



Primary Outcome Measures :
  1. 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.


  2. 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. Mean transit time (MTT) on Admission [ Time Frame: 3 days from the attack ]
    Mean transit time (MTT) on Admission in units of seconds.


Secondary Outcome Measures :
  1. 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.

  2. 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. 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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients having subarachnoid hemorrhage whether post aneurysmal or spontaneous
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03214705


Locations
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Egypt
Mohamed Abdel-Tawab Mohamed
Assiut, Egypt, 71511
Sponsors and Collaborators
Assiut University
Investigators
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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

Additional Information:

Publications:
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Responsible Party: Mohamed Abdel-Tawab Mohamed, Assistant Lecturer, Assiut University
ClinicalTrials.gov Identifier: NCT03214705     History of Changes
Other Study ID Numbers: CTP predicts DCI
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mohamed Abdel-Tawab Mohamed, Assiut University:
CT perfusion
Subarachnoid hemorrhage
Vasospasm
Delayed cerebral ischemia

Additional relevant MeSH terms:
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Hemorrhage
Subarachnoid Hemorrhage
Intracranial Hemorrhages
Ischemia
Brain Ischemia
Cerebral Infarction
Vasospasm, Intracranial
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Stroke