NCT03214705

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 29, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 11, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2018

Completed
Last Updated

September 16, 2021

Status Verified

September 1, 2021

Enrollment Period

1.9 years

First QC Date

June 29, 2017

Last Update Submit

September 15, 2021

Conditions

Keywords

CT perfusionSubarachnoid hemorrhageVasospasmDelayed cerebral ischemia

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • Mean transit time (MTT) on Admission

    Mean transit time (MTT) on Admission in units of seconds.

    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

    4-14 days from the attack

  • Hunt and Hess scale

    3 days from the attack

  • Fisher scale

    3 days from the attack

Study Arms (2)

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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients having subarachnoid hemorrhage whether post aneurysmal or spontaneous

You may qualify if:

  • All patients presented with subarachnoid haemorrhage

You may not qualify if:

  • Patients with abnormal renal functions with creatinine ≥ 2 mg/dl/
  • Patients with hypersensitivity to contrast media.
  • Contraindication to radiation as pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohamed Abdel-Tawab Mohamed

Asyut, 71511, Egypt

Location

Related 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.

    PMID: 18850093BACKGROUND
  • 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.

    PMID: 17416833BACKGROUND
  • 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.

    PMID: 20689085BACKGROUND
  • 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.

    PMID: 22264777BACKGROUND
  • 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.

    PMID: 18466974BACKGROUND

MeSH Terms

Conditions

Subarachnoid HemorrhageVasospasm, Intracranial

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mohamed Abdel-Tawab

    Assiut University

    PRINCIPAL INVESTIGATOR
  • Afaf A. Hasan, Profosser

    Assiut University

    STUDY CHAIR
  • Mohamed A. Ahmed, Professor

    Assiut University

    STUDY DIRECTOR
  • Hany M. Seif, Professor

    Assiut University

    STUDY DIRECTOR
  • Hazem A. Youssef, Professor

    Assiut unviersity

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
21 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

June 29, 2017

First Posted

July 11, 2017

Study Start

March 1, 2016

Primary Completion

February 1, 2018

Study Completion

February 28, 2018

Last Updated

September 16, 2021

Record last verified: 2021-09

Locations