Clinical trial NCT03214705: Role of CT Perfusion in Predicting Poor Outcome After Subarachnoid Hemorrhage
Official title: Role of Computed Tomography Perfusion in Detection of Patients at Risk for Delayed Cerebral Ischemia After Subarachnoid Hemorrhage
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Subarachnoid Hemorrhage
Cerebral Vasospasm
Delayed Cerebral Ischemia
Keywords: CT perfusion
Subarachnoid hemorrhage
Vasospasm
Delayed cerebral ischemia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-07-11
Enrollment: 64
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients having subarachnoid hemorrhage whether post aneurysmal or spontaneous

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.

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.

Eligibility 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.

Primary outcomes:
measure: Cerebral blood flow (CBF) on Admission
timeFrame: 3 days from the attack
measure: Cerebral blood volume (CBV) on Admission
timeFrame: 3 days from the attack
measure: Mean transit time (MTT) on Admission
timeFrame: 3 days from the attack
Secondary outcomes:
measure: Correlation of vasospasm to perfusion abnormality using Comparing between CT angiography and CT perfusion in patients with subarachnoid hemorrhage
timeFrame: 4-14 days from the attack
measure: Hunt and Hess scale
timeFrame: 3 days from the attack
measure: Fisher scale
timeFrame: 3 days from the attack
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Mohamed Abdel-Tawab Mohamed
Study officials:
affiliation: Assiut University
name: Mohamed Abdel-Tawab
role: PRINCIPAL_INVESTIGATOR
affiliation: Assiut University
name: Afaf A. Hasan, Profosser
role: STUDY_CHAIR
affiliation: Assiut University
name: Mohamed A. Ahmed, Professor
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Hany M. Seif, Professor
role: STUDY_DIRECTOR
affiliation: Assiut unviersity
name: Hazem A. Youssef, Professor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Binaghi S, Colleoni ML, Maeder P, Uske 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.
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.
citation: Munoz-Guillen NM, Leon-Lopez R, Tunez-Finana I, Cano-Sanchez 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. English, Spanish.
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.