Subarachnoid HemorrhageNCT03214705
Role of CT Perfusion in Predicting Poor Outcome After Subarachnoid Hemorrhage
An observational study of Subarachnoid Hemorrhage and Cerebral Vasospasm, run by Assiut University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Subarachnoid Hemorrhage, Cerebral Vasospasm, Delayed Cerebral Ischemia
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2016to 28 Feb 2018
- How long will I take part?
- 21 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients having subarachnoid hemorrhage whether post aneurysmal or spontaneous
Who may be able to join
- All patients presented with subarachnoid haemorrhage
Who cannot join
- Patients with abnormal renal functions with creatinine ≥ 2 mg/dl/
- Patients with hypersensitivity to contrast media.
- Contraindication to radiation as pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Keywords
- CT perfusion, Subarachnoid hemorrhage, Vasospasm, Delayed cerebral ischemia
- Medical subject headings
- Subarachnoid Hemorrhage, Vasospasm, Intracranial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 days from the attack
Cerebral blood volume (CBV) on Admission
Cerebral blood volume (CBF) on Admission in units of ml/100 gram brain tissue.
Measured: 3 days from the attack
Mean transit time (MTT) on Admission
Mean transit time (MTT) on Admission in units of seconds.
Measured: 3 days from the attack
Secondary outcomes (3)
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.
Measured: 4-14 days from the attack
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
Measured: 3 days from the attack
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
Measured: 3 days from the attack
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start1 Mar 2016
- Primary completion1 Feb 2018
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Subarachnoid HemorrhageStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
- Target duration
- 21 Days
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abdel-Tawab Mohamed, Assiut University
- Investigators
- Mohamed Abdel-Tawab, Principal investigator, Assiut UniversityAfaf A. Hasan, Profosser, Study chair, Assiut UniversityMohamed A. Ahmed, Professor, Study director, Assiut UniversityHany M. Seif, Professor, Study director, Assiut UniversityHazem A. Youssef, Professor, Study director, Assiut unviersity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03214705
- Sponsor's protocol ID
- CTP predicts DCI
- Status last verified
- Sep 2021
- First submitted
- 29 Jun 2017
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 18850093Binaghi 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.
PubMed 17416833Dankbaar 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.
PubMed 20689085Munoz-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.
PubMed 22264777Wintermark 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.
PubMed 18466974
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Computed Tomography Perfusion in Detection of Patients at Risk for Delayed Cerebral Ischemia After Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT03214705
- Acronym / sponsor ID
- CTP predicts DCI
- Keywords
- CT perfusion, Subarachnoid hemorrhage, Vasospasm, Delayed cerebral ischemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 11 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 21 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients having subarachnoid hemorrhage whether post aneurysmal or spontaneous
Key inclusion criteria (1 listed)
- All patients presented with subarachnoid haemorrhage
Key exclusion criteria (3 listed)
- Patients with abnormal renal functions with creatinine ≥ 2 mg/dl/
- Patients with hypersensitivity to contrast media.
- Contraindication to radiation as pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Mean transit time (MTT) on Admission
Time frame: 3 days from the attack
Mean transit time (MTT) on Admission in units of seconds.
3 secondary outcomes
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
Hunt and Hess scale
Time frame: 3 days from the attack
Fisher scale
Time frame: 3 days from the attack
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Background: PubMed 18850093Aralasmak 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.
- Background: PubMed 17416833Binaghi 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.
- Background: PubMed 20689085Dankbaar 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.
- Background: PubMed 22264777Munoz-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.
- Background: PubMed 18466974Wintermark 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Abdel-Tawab principal investigator
Assiut University
Afaf A. Hasan, Profosser study chair
Assiut University
Mohamed A. Ahmed, Professor study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subarachnoid Hemorrhage and Cerebral Vasospasm, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral blood flow (CBF) on Admission (time frame: 3 days from the attack). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03214705, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021.