Role of CT Perfusion in Predicting Poor Outcome After Subarachnoid Hemorrhage

Subarachnoid Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03214705
• Other study ID #: CTP predicts DCI
• Status: Completed
• Start date: March 1, 2016
• Est. completion date: February 28, 2018

Study information

• Verified date: September 2021
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: February 28, 2018
• Est. primary completion date: February 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Ischemia
• Cerebral Infarction
• Cerebral Vasospasm
• Delayed Cerebral Ischemia
• Hemorrhage
• Ischemia
• Subarachnoid Hemorrhage
• Vasospasm, Intracranial

Locations

Country	Name	City	State
Egypt	Mohamed Abdel-Tawab Mohamed	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

Aralasmak A, Akyuz M, Ozkaynak C, Sindel T, Tuncer R. CT angiography and perfusion imaging in patients with subarachnoid hemorrhage: correlation of vasospasm to perfusion abnormality. Neuroradiology. 2009 Feb;51(2):85-93. doi: 10.1007/s00234-008-0466-7. Epub 2008 Oct 11. — View Citation

Binaghi S, Colleoni ML, Maeder P, Uské A, Regli L, Dehdashti AR, Schnyder P, Meuli R. CT angiography and perfusion CT in cerebral vasospasm after subarachnoid hemorrhage. AJNR Am J Neuroradiol. 2007 Apr;28(4):750-8. — View Citation

Dankbaar JW, de Rooij NK, Rijsdijk M, Velthuis BK, Frijns CJ, Rinkel GJ, van der Schaaf IC. Diagnostic threshold values of cerebral perfusion measured with computed tomography for delayed cerebral ischemia after aneurysmal subarachnoid hemorrhage. Stroke. 2010 Sep;41(9):1927-32. doi: 10.1161/STROKEAHA.109.574392. Epub 2010 Aug 5. — View Citation

Muñoz-Guillén NM, León-López R, Túnez-Fiñana I, Cano-Sánchez A. From vasospasm to early brain injury: new frontiers in subarachnoid haemorrhage research. Neurologia. 2013 Jun;28(5):309-16. doi: 10.1016/j.nrl.2011.10.015. Epub 2012 Jan 21. Review. English, Spanish. — View Citation

Wintermark M, Sincic R, Sridhar D, Chien JD. Cerebral perfusion CT: technique and clinical applications. J Neuroradiol. 2008 Dec;35(5):253-60. doi: 10.1016/j.neurad.2008.03.005. Epub 2008 May 7. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebral blood flow (CBF) on Admission	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
Primary	Cerebral blood volume (CBV) on Admission	Cerebral blood volume (CBF) on Admission in units of ml/100 gram brain tissue.	3 days from the attack
Primary	Mean transit time (MTT) on Admission	Mean transit time (MTT) on Admission in units of seconds.	3 days from the attack
Secondary	Correlation of vasospasm to perfusion abnormality using Comparing between CT angiography and CT perfusion in patients with subarachnoid hemorrhage	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
Secondary	Hunt and Hess scale	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
Secondary	Fisher scale	Fisher scale quantifies the amount of SAH as the following: None evident; Less than 1 mm thick; More than 1 mm thick; Diffuse or none with intraventricular hemorrhage or parenchymal extension	3 days from the attack