Back to resultsAssessment of Intracerebral Hematoma
Primary Purpose
Intracerebral Hematoma
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
transcranial duplex sonography
Sponsored by
About this trial
This is an interventional diagnostic trial for Intracerebral Hematoma
Eligibility Criteria
Inclusion Criteria:
- first ever non traumatic supratentorial primary intracerebral haemorrhage on non contrast CT brain
- admitted within 24 hours of symptom onset
Exclusion Criteria:
- blood diseases, decompansated hepatic or renal impairment, or encephalopathy caused by electrolyte disturbance
- on anticoagulant treatment
- if devolped major complications during hospitalization ( e.g sever chest infection, hypoxia, or deep venous thrombosis )
- comorbid neurological or psychiatric disorders
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
patients assessed by transcranial duplex sonography
Arm Description
Outcomes
Primary Outcome Measures
change from baseline in volume of intracerebral hematoma
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05158660
Brief Title
Assessment of Intracerebral Hematoma
Official Title
Assessment of Intracerebral Hematoma Using Transcranial Duplex _ Hospital Based Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2022 (Anticipated)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
January 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The study will assess acute intracerebral hematoma expansion within the first 48 hours from the onset using transcranial duplex sonography in patients who have acute intracerebral hematoma , and will also assess the correlation between the transcranial duplex sonography measurements and the clinical outcome of these patients .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracerebral Hematoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
patients assessed by transcranial duplex sonography
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
transcranial duplex sonography
Intervention Description
it is an imaging device that will measure the intracerebral hematoma expansion
Primary Outcome Measure Information:
Title
change from baseline in volume of intracerebral hematoma
Time Frame
at baseline, then 24 hour after the baseline, and finally 48 hours after the baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
first ever non traumatic supratentorial primary intracerebral haemorrhage on non contrast CT brain
admitted within 24 hours of symptom onset
Exclusion Criteria:
blood diseases, decompansated hepatic or renal impairment, or encephalopathy caused by electrolyte disturbance
on anticoagulant treatment
if devolped major complications during hospitalization ( e.g sever chest infection, hypoxia, or deep venous thrombosis )
comorbid neurological or psychiatric disorders
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
waleed Gafar
Phone
00201012110708
Email
waleed.gafar1995@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Assessment of Intracerebral Hematoma
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