Subdural HematomaNCT06119932
Evaluation of One Burr Hole Evacuation for Subdural Hematoma
An observational study of Subdural Hematoma, run by Assiut University at 2 sites in Egypt.
Trial summary
To evaluate the outcome of one burrhole evacuation for subdural hematoma and it has the same result of traditional two burrhole Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subdural Hematoma
- What is being tested?
- Evacuation for subdural hematoma by one burrhole
- Type of treatment
- Surgery or procedure
- How many people
- 35 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Nov 2023to 1 Oct 2024
- Phase
- Observational
- 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
Study population: Both sex Adult obove 18 years old
Who may be able to join
- Patients with subdural hematoma either unilateral or bilateral
- fit for surgery
- Chronic SDH
- Subacute SDH
- Age: patients older than 18 years old
- SEX: Both sex
Who cannot join
- Patients unfit for surgery
- Acute SDH
- subdural hyroma
- subdural empyema
- patient treated conservatively
Trial locations and contacts
2 sites in 1 country.
Ahmed Abo kresha, Professor contact
Egypt2 sites
Mohammed lotfi abdelkareem
Asyut, 71515
Mohammed Lotfi
Mohammed lotfi abdelkareem
Minya, Malawi, 61631
Mohammed Lotfi a, Reseddnt
About this study
To evaluate the outcome of one burrhole evacuation for subdural hematoma and it has the same result of traditional two burrhole
Read the detailed description
- Subdural hematoma (SDH): abnormal Collection of Liquefied blood degradation underneath the dura matter (1.2.3).
- one of the most frequent types of intracranial haemorrhage, That is still associated with significant morbidity (1.4.5).
- The SDH: is a common disease in elderly Patient, and Its Incidence is highest in persons older than 70 Years of age (1.5).
- Types of Subdural hematoma(18.19) 1- Acute: present within 48-72 hours of injury. 2. Sub-acute: manifest itself between 3-20 day. 3- Chronic (CH): produce symptoms from 3 weeks to several months after injury Risk Factors: (7.8.9.10.11.12)
- Trauma; mostly minor Trauma, Approximately two thirds of The Patients have suffered one. Reports exist of chronic SDH due to birth trauma in neonates.
- Advanced age: The elderly are at risk due to:
- brain atrophy, whereby The bridging veins are stretched and become more fragile.
- Older People tend to fall more often and Suffer minor head trauma.
- With increase age, The incidence of blood Thinner administration raises leading to increased risk for haemorrhage
- Chronic alcoholism:
- Gender: men, from all age groups, suffer higher rates of chsDH than woman.
- CoagulaPathy: Therapeutic anticoagulation and antiplatelet therapy.
- Medical Conditions: sepsis, hepatic failure, hemophilia, DIC and renal dialysis.
- Intracranial hypotension: as after ventriculoperitoneal shunt. clinical presentation (1.13)
- Symptoms of increase intra cranial pressure: Headache, Nausea, vomiting.
- Focal neurological deficit - (weakness, aphasia).
- Disturbed conscious level (DCL)
- Seizures
- Imaging investigation:
CT brain (14.15)
- Management : (1.6.16.17)
- Conservative: A watch, wait and re-scan Policy is usually recommended in asymptomatic or minimally symptomatic patient with a thin CHSDH.
- Surgical: For symptomatic (SDH) a- burr hole drainage B-twist drill drainage c- craniotomy
- prognostic factors : (2.5) 1- age of patient 2- Associated chronic diseases like hypertension, liver diseases …….Etc 3- Laboratory investigation like Hb , platlate count ,pc,and PT. 5- Hematoma thickness 6- number of burr hole : one or two burr hole
- Conditions
- Subdural Hematoma
- Being tested
- Evacuation for subdural hematoma by one burrhole
- Medical subject headings
- Hematoma, Subdural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evacuation for subdural hematoma by one burrholeProcedure or surgery
Evacuation for subdural hematoma by one burrhole
What is being measured
The primary outcome is the main question the study is designed to answer.
ClinicalEvaluation of evacuation for subdural hematoma by one burrhole
- glasgo coma scale,
- neurological deficit,
- clinical symptoms (seizures) .
Measured: 72 hours post operative
Secondary outcomes (1)
Radiological evaluation for outcome
Nearly gross total evacuation according to confirmation by postoperative CT brain
Measured: 72 hours post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start1 Nov 2023 (estimated)
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subdural 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed lotfi abdelkareem, Assiut University
- Investigators
- Shady Hassaan, Study director, Lecturer of Neurosurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06119932
- Sponsor's protocol ID
- Subdural hematoma
- Status last verified
- Oct 2023
- First submitted
- 10 Oct 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of One Burr Hole Evacuation for Subdural Hematoma
- ClinicalTrials.gov ID
- NCT06119932
- Acronym / sponsor ID
- Subdural hematoma
- Conditions
- Subdural Hematoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 7 Nov 2023 (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.
To evaluate the outcome of one burrhole evacuation for subdural hematoma and it has the same result of traditional two burrhole
Detailed description
- Subdural hematoma (SDH): abnormal Collection of Liquefied blood degradation underneath the dura matter (1.2.3).
- one of the most frequent types of intracranial haemorrhage, That is still associated with significant morbidity (1.4.5).
- The SDH: is a common disease in elderly Patient, and Its Incidence is highest in persons older than 70 Years of age (1.5).
- Types of Subdural hematoma(18.19) 1- Acute: present within 48-72 hours of injury. 2. Sub-acute: manifest itself between 3-20 day. 3- Chronic (CH): produce symptoms from 3 weeks to several months after injury Risk Factors: (7.8.9.10.11.12)
- Trauma; mostly minor Trauma, Approximately two thirds of The Patients have suffered one. Reports exist of chronic SDH due to birth trauma in neonates.
- Advanced age: The elderly are at risk due to:
- brain atrophy, whereby The bridging veins are stretched and become more fragile.
- Older People tend to fall more often and Suffer minor head trauma.
- With increase age, The incidence of blood Thinner administration raises leading to increased risk for haemorrhage
- Chronic alcoholism:
- Gender: men, from all age groups, suffer higher rates of chsDH than woman.
- CoagulaPathy: Therapeutic anticoagulation and antiplatelet therapy.
- Medical Conditions: sepsis, hepatic failure, hemophilia, DIC and renal dialysis.
- Intracranial hypotension: as after ventriculoperitoneal shunt. clinical presentation (1.13)
- Symptoms of increase intra cranial pressure: Headache, Nausea, vomiting.
- Focal neurological deficit - (weakness, aphasia).
- Disturbed conscious level (DCL)
- Seizures
- Imaging investigation:
CT brain (14.15)
- Management : (1.6.16.17)
- Conservative: A watch, wait and re-scan Policy is usually recommended in asymptomatic or minimally symptomatic patient with a thin CHSDH.
- Surgical: For symptomatic (SDH) a- burr hole drainage B-twist drill drainage c- craniotomy
- prognostic factors : (2.5) 1- age of patient 2- Associated chronic diseases like hypertension, liver diseases …….Etc 3- Laboratory investigation like Hb , platlate count ,pc,and PT. 5- Hematoma thickness 6- number of burr hole : one or two burr hole
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Both sex Adult obove 18 years old
Key inclusion criteria (6 listed)
- Patients with subdural hematoma either unilateral or bilateral
- fit for surgery
- Chronic SDH
- Subacute SDH
- Age: patients older than 18 years old
Key exclusion criteria (5 listed)
- Patients unfit for surgery
- Acute SDH
- subdural hyroma
- subdural empyema
- patient treated conservatively
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 |
|---|---|---|
| Evacuation for subdural hematoma by one burrholeEvacuation for subdural hematoma by one burrhole | Procedure or surgery | – |
Primary outcome
ClinicalEvaluation of evacuation for subdural hematoma by one burrhole
Time frame: 72 hours post operative
* glasgo coma scale, * neurological deficit, * clinical symptoms (seizures) .
1 secondary outcome
Radiological evaluation for outcome
Time frame: 72 hours post operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
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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.
Ahmed Abo kresha, Professor contact
Shady Hassaan study director
Lecturer of Neurosurgery
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subdural Hematoma, run by Assiut University at 2 sites in Egypt.
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 6 inclusion and 5 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 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Mohammed Lotfi, Resident (01147341661, Mohammedlotfi029@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ClinicalEvaluation of evacuation for subdural hematoma by one burrhole (time frame: 72 hours post operative). 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 7 Nov 2023.