Intracerebral HematomaNCT05158660
Assessment of Intracerebral Hematoma
A study testing transcranial duplex sonography in people with Intracerebral Hematoma, run by Assiut University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracerebral Hematoma
- What is being tested?
- transcranial duplex sonography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jan 2022to Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- first ever non traumatic supratentorial primary intracerebral haemorrhage on non contrast CT brain
- admitted within 24 hours of symptom onset
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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 .
- Conditions
- Intracerebral Hematoma
- Being tested
- transcranial duplex sonography
- Medical subject headings
- Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial duplex sonographyDevice
it is an imaging device that will measure the intracerebral hematoma expansion
| Study group | Role | What they receive |
|---|---|---|
| patients assessed by transcranial duplex sonography | Experimental | Not described Receives: Device: transcranial duplex sonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline in volume of intracerebral hematoma
Measured: at baseline, then 24 hour after the baseline, and finally 48 hours after the baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study startJan 2022 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracerebral HematomaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waleed Mohammed Gafar, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05158660
- Sponsor's protocol ID
- intracerebral hematoma
- Status last verified
- Dec 2021
- First submitted
- 3 Dec 2021
- Last updated
- 15 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Intracerebral Hematoma Using Transcranial Duplex _ Hospital Based Study
- ClinicalTrials.gov ID
- NCT05158660
- Acronym / sponsor ID
- intracerebral hematoma
- Conditions
- Intracerebral Hematoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2022 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 15 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients assessed by transcranial duplex sonography | Experimental | Device: transcranial duplex sonography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- first ever non traumatic supratentorial primary intracerebral haemorrhage on non contrast CT brain
- admitted within 24 hours of symptom onset
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcranial duplex sonographyit is an imaging device that will measure the intracerebral hematoma expansion | Device | patients assessed by transcranial duplex sonography |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial duplex sonography in people with Intracerebral Hematoma, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact waleed Gafar (00201012110708, waleed.gafar1995@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2021.