Assessment of Intracerebral Hematoma

Assessment of Intracerebral Hematoma Using Transcranial Duplex _ Hospital Based Study

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 .

Study Overview

• Status: Not yet recruiting
• Conditions: Intracerebral Hematoma
• Intervention / Treatment: Device: transcranial duplex sonography

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: waleed Gafar; Phone Number: 00201012110708; Email: waleed.gafar1995@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. first ever non traumatic supratentorial primary intracerebral haemorrhage on non contrast CT brain
2. admitted within 24 hours of symptom onset

Exclusion Criteria:

1. blood diseases, decompansated hepatic or renal impairment, or encephalopathy caused by electrolyte disturbance
2. on anticoagulant treatment
3. if devolped major complications during hospitalization ( e.g sever chest infection, hypoxia, or deep venous thrombosis )
4. comorbid neurological or psychiatric disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: patients assessed by transcranial duplex sonography	Device: transcranial duplex sonography; it is an imaging device that will measure the intracerebral hematoma expansion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
change from baseline in volume of intracerebral hematoma	at baseline, then 24 hour after the baseline, and finally 48 hours after the baseline

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2022
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): January 1, 2023

Study Registration Dates

• First Submitted: December 3, 2021
• First Submitted That Met QC Criteria: December 3, 2021
• First Posted (Actual): December 15, 2021

Study Record Updates

• Last Update Posted (Actual): December 15, 2021
• Last Update Submitted That Met QC Criteria: December 3, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hemorrhage; Intracranial Hemorrhages; Cerebral Hemorrhage; Hematoma
• Other Study ID Numbers: intracerebral hematoma

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No