Assessment of Intracerebral Hematoma

• Sponsor: Assiut University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05158660
• Collaborator: (none)
• Enrollment: 120
• Arm: 1
• Anticipated Duration (Months): 12

Study Details

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 .

Condition or Disease	Intervention/Treatment	Phase
Intracerebral Hematoma	Device: transcranial duplex sonography	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Assessment of Intracerebral Hematoma Using Transcranial Duplex _ Hospital Based Study
• Anticipated Study Start Date: Jan 1, 2022
• Anticipated Primary Completion Date: Oct 1, 2022
• Anticipated Study Completion Date: Jan 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. change from baseline in volume of intracerebral hematoma [at baseline, then 24 hour after the baseline, and finally 48 hours after the baseline]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Waleed Mohammed Gafar, Doctor, Assiut University
• ClinicalTrials.gov Identifier: NCT05158660
• Other Study ID Numbers: intracerebral hematoma
• First Posted: Dec 15, 2021
• Last Update Posted: Dec 15, 2021
• Last Verified: Dec 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cerebral Hemorrhage; Hematoma

Study Results

No Results Posted as of Dec 15, 2021