Assessment of Intracerebral Hematoma | NCT05158660

Studies
Assessment of Intracerebral Hematoma

NCT05158660

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Dec 15, 2021Actual

Enrollment

120Estimated

Phase

Not Applicable

Conditions

Intracerebral Hematoma

Interventions

transcranial duplex sonography

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2022Estimated

Primary Completion Date

Oct 2022Estimated

Completion Date

Jan 2023Estimated

First Submitted Date

Dec 3, 2021

First Submission Date that Met QC Criteria

Dec 3, 2021

First Posted Date

Dec 15, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 3, 2021

Last Update Posted Date

Dec 15, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 .

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
patients assessed by transcranial duplex sonography	Experimental		Device: transcranial duplex sonography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
transcranial duplex sonography	Device	it is an imaging device that will measure the intracerebral hematoma expansion	patients assessed by transcranial duplex sonography

Outcomes Module

Primary Outcomes

Measure	Description	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
waleed Gafar	Contact	00201012110708		waleed.gafar1995@gmail.com

Overall Officials

Not provided

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002543	Cerebral Hemorrhage

Ancestor Terms

ID	Term
D020300	Intracranial Hemorrhages
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided