NCT05158660

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 .

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Status
unknown

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

First Submitted

Initial submission to the registry

December 3, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 15, 2021

Completed
17 days until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

December 15, 2021

Status Verified

December 1, 2021

Enrollment Period

9 months

First QC Date

December 3, 2021

Last Update Submit

December 3, 2021

Conditions

Intracerebral Hematoma

Outcome Measures

Primary Outcomes (1)

  • change from baseline in volume of intracerebral hematoma

    at baseline, then 24 hour after the baseline, and finally 48 hours after the baseline

Study Arms (1)

patients assessed by transcranial duplex sonography

EXPERIMENTAL
Device: transcranial duplex sonography

Interventions

transcranial duplex sonographyDEVICE

it is an imaging device that will measure the intracerebral hematoma expansion

patients assessed by transcranial duplex sonography

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

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

Central Study Contacts

waleed Gafar

CONTACT

00201012110708waleed.gafar1995@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

December 3, 2021

First Posted

December 15, 2021

Study Start

January 1, 2022

Primary Completion

October 1, 2022

Study Completion

January 1, 2023

Last Updated

December 15, 2021

Record last verified: 2021-12