Chronic Non-Traumatic Intracranial Subdural HaemorrhageNCT06743893
Non Traumatic Chronic Subdural Haematoma in Paediatric Age Groups, Management and Outcome
An observational study of Chronic Non-Traumatic Intracranial Subdural Haemorrhage, run by Assiut University.
Trial summary
1-Review the management strategies and outcomes in cases of non traumatic chronic subdural haematoma in paediatric age group. 2- Review the underlying causes and risk factors in cases of non traumatic chronic subdural haematoma in paediatric age group Read more about this study
- Who is it for?
- Ages 1 hour to 18 years
- Conditions the study is for
- Chronic Non-Traumatic Intracranial Subdural Haemorrhage
- What is being tested?
- Diagnosis and outcome of non traumatic chronic subdural haematoma in pediatric age groups
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2024to 15 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 1 hour to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: pediatric age group from first hour after birth of newborn till 18 years old
Inclusion Criteria:1-Age less than 18 years. 2-patient with subdural haematoma other than traumatic -
Exclusion Criteria:1-Age more than 18 years. 2-patient with traumatic subdural haematoma. 3- patient unfit for surgery
-
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Abdelrahaman Abobakr Abass, Bachelor of medicine degree contact
About this study
1-Review the management strategies and outcomes in cases of non traumatic chronic subdural haematoma in paediatric age group. 2- Review the underlying causes and risk factors in cases of non traumatic chronic subdural haematoma in paediatric age group
Read the detailed description
2.4.1- Type of the study: prospective case series study 2.4. 2- Study Setting: Neurosurgery department Assiut university hospital 2.4. 3- Study subjects:
- Inclusion criteria: 1-Age less than 18 years. 2-patient with subdural haematoma other than traumatic
- Exclusion criteria: 1-Age more than 18 years. 2-patient with traumatic subdural haematoma. 3- patient unfit for surgery Patient and method: 1-General examination. 2- Neurological examination. 3- complete basal investigations. 4-Imaging brain CT scan In paediatric patients with subdural hematoma with an amount of bleeding requiring surgical management, any underlying comorbidities should be investigated regardless of the presence of a history of trauma. While investigating systemic diseases, special attention should be paid to the presence of arachnoid cysts or disruption in cerebrospinal fluid dynamics along with a history of hematologic diseases Data on patient sex, age, bleeding location, type of hematoma based on computed tomography imaging, surgical treatment, presenting symptoms, presence of comorbidities, Glasgow Coma Scale, platelets counts, and international normalized ratio values were recorded There will be file to collect data ( patient data sheet)of the patient: involving personal data and detailed history and detailed general and neurological examinations and all general investigations and specific according to her underlying medical disorders ( risk factor and cause of non traumatic subdural haematoma) and type of treatment that received and report of ct scan and mri Symptoms of subdural haematoma: Drowsy/unconscious , Poor feeding , Irritability , Fits , Pallor , Floppiness , Vomiting , Sudden collapse, Breathing difficulties , Large head , Apnoea , Delayed development Neurological assessment plus Glasgow Coma Scale(paediatric GCS and pupillary reactivity) Investigations: CT scan brain MRI BRAIN : cranial subdural haematoma site and location , size in cm, detected midline shift ,uni or bilateral subdural haematoma, haematoma density , haematoma thickness plus other cranial bleeding or pathology or other spinal cord bleeding or pathology All blood investigations including cbc , coagulation profile , liver ,renal functions , all investigations related to underlying medical or neurological or neurosurgical disorder. Treatment: admission either in intensive care unit ,or in the department and type of treatment either medical with conservative involving dexamethasone plus or minus atrovostatins(2.5-5 mg atorvastatin daily combined with dexamethasone with stepwise-decreasing dosing for a total of 4 weeks) Or surgical in the form of burr hole trepanation (Burr-hole drainage (BHD), craniectomy and craniotomy After treatment follow up for 2 days , one month and three months post operative.
- Sample Size Calculation: 30 cases according previous case series studies in these rare disease and according to sample size calculation.
2.4.4 -Study tools (in detail, e.g., lab methods, instruments, steps, chemicals, …):CT scan brain MRI BRAIN detected site and location of cranial subdural haematoma ,midline shift uni or bilateral subdural haematoma, haematoma density , haematoma thickness plus other cranial bleeding or pathology or other spinal cord bleeding or pathology All blood investigations including cbc , coagulation profile , liver ,renal functions , all investigations related to underlying medical or neurological or neurosurgical disorder There will be file to collect data ( patient data sheet)of the patient involving personal data and detailed history and detailed general and neurological examinations and all general investigations and specific according to her underlying medical disorders ( risk factor and cause of non traumatic cranial subdural haematoma) and type of treatment that received and report of ct scan and mri
- Being tested
- Diagnosis and outcome of non traumatic chronic subdural haematoma in pediatric age groups
- Keywords
- chronic- subdural haematoma- non traumatic-pediatric age group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnosis and outcome of non traumatic chronic subdural haematoma in pediatric age groupsOther
Diagnosis and outcome of non traumatic chronic subdural haematoma in pediatric age groups
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnosis and outcome of different types of treatment of non traumatic chronic subdural haematoma in paediatric age group in within one year.
diagnosis and outcome of different types of treatment of non traumatic chronic subdural haematoma in paediatric age group.
Measured: one year
Secondary outcomes (1)
Secondary (subsidiary): the underlying risk factors and possible relation to non traumatic chronic subdural haematoma in paediatric age group and how to decrease its recurrence
Secondary (subsidiary): the underlying risk factors and possible relation to non traumatic chronic subdural haematoma in paediatric age group and how to decrease its recurrence
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start15 Dec 2024 (estimated)
- Primary completion15 Dec 2025 (estimated)
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Non-Traumatic Intracranial Subdural HaemorrhageStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, abo bakr mitwally, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06743893
- Sponsor's protocol ID
- NTCSDH
- Status last verified
- Dec 2024
- First submitted
- 17 Dec 2024
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Traumatic Chronic Subdural Haematoma in Paediatric Age Groups, Management and Outcome
- ClinicalTrials.gov ID
- NCT06743893
- Acronym / sponsor ID
- NTCSDH
- Keywords
- chronic- subdural haematoma- non traumatic-pediatric age group
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Dec 2024 (estimated)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 20 Dec 2024 (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.
1-Review the management strategies and outcomes in cases of non traumatic chronic subdural haematoma in paediatric age group. 2- Review the underlying causes and risk factors in cases of non traumatic chronic subdural haematoma in paediatric age group
Detailed description
2.4.1- Type of the study: prospective case series study 2.4. 2- Study Setting: Neurosurgery department Assiut university hospital 2.4. 3- Study subjects:
- Inclusion criteria: 1-Age less than 18 years. 2-patient with subdural haematoma other than traumatic
- Exclusion criteria: 1-Age more than 18 years. 2-patient with traumatic subdural haematoma. 3- patient unfit for surgery Patient and method: 1-General examination. 2- Neurological examination. 3- complete basal investigations. 4-Imaging brain CT scan In paediatric patients with subdural hematoma with an amount of bleeding requiring surgical management, any underlying comorbidities should be investigated regardless of the presence of a history of trauma. While investigating systemic diseases, special attention should be paid to the presence of arachnoid cysts or disruption in cerebrospinal fluid dynamics along with a history of hematologic diseases Data on patient sex, age, bleeding location, type of hematoma based on computed tomography imaging, surgical treatment, presenting symptoms, presence of comorbidities, Glasgow Coma Scale, platelets counts, and international normalized ratio values were recorded There will be file to collect data ( patient data sheet)of the patient: involving personal data and detailed history and detailed general and neurological examinations and all general investigations and specific according to her underlying medical disorders ( risk factor and cause of non traumatic subdural haematoma) and type of treatment that received and report of ct scan and mri Symptoms of subdural haematoma: Drowsy/unconscious , Poor feeding , Irritability , Fits , Pallor , Floppiness , Vomiting , Sudden collapse, Breathing difficulties , Large head , Apnoea , Delayed development Neurological assessment plus Glasgow Coma Scale(paediatric GCS and pupillary reactivity) Investigations: CT scan brain MRI BRAIN : cranial subdural haematoma site and location , size in cm, detected midline shift ,uni or bilateral subdural haematoma, haematoma density , haematoma thickness plus other cranial bleeding or pathology or other spinal cord bleeding or pathology All blood investigations including cbc , coagulation profile , liver ,renal functions , all investigations related to underlying medical or neurological or neurosurgical disorder. Treatment: admission either in intensive care unit ,or in the department and type of treatment either medical with conservative involving dexamethasone plus or minus atrovostatins(2.5-5 mg atorvastatin daily combined with dexamethasone with stepwise-decreasing dosing for a total of 4 weeks) Or surgical in the form of burr hole trepanation (Burr-hole drainage (BHD), craniectomy and craniotomy After treatment follow up for 2 days , one month and three months post operative.
- Sample Size Calculation: 30 cases according previous case series studies in these rare disease and according to sample size calculation.
2.4.4 -Study tools (in detail, e.g., lab methods, instruments, steps, chemicals, …):CT scan brain MRI BRAIN detected site and location of cranial subdural haematoma ,midline shift uni or bilateral subdural haematoma, haematoma density , haematoma thickness plus other cranial bleeding or pathology or other spinal cord bleeding or pathology All blood investigations including cbc , coagulation profile , liver ,renal functions , all investigations related to underlying medical or neurological or neurosurgical disorder There will be file to collect data ( patient data sheet)of the patient involving personal data and detailed history and detailed general and neurological examinations and all general investigations and specific according to her underlying medical disorders ( risk factor and cause of non traumatic cranial subdural haematoma) and type of treatment that received and report of ct scan and mri
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 hour to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- pediatric age group from first hour after birth of newborn till 18 years old
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 |
|---|---|---|
| Diagnosis and outcome of non traumatic chronic subdural haematoma in pediatric age groupsDiagnosis and outcome of non traumatic chronic subdural haematoma in pediatric age groups | Other | – |
Primary outcome
diagnosis and outcome of different types of treatment of non traumatic chronic subdural haematoma in paediatric age group in within one year.
Time frame: one year
diagnosis and outcome of different types of treatment of non traumatic chronic subdural haematoma in paediatric age group.
1 secondary outcome
Secondary (subsidiary): the underlying risk factors and possible relation to non traumatic chronic subdural haematoma in paediatric age group and how to decrease its recurrence
Time frame: one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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.
Abdelrahaman Abobakr Abass, Bachelor of medicine degree contact
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Non-Traumatic Intracranial Subdural Haemorrhage, 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?
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: opening soon, as of the sponsor's last update on 20 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abdelrahaman Abobakr Abass, Bachelor of medicine degree (0020882132478, abdelrahman1615@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnosis and outcome of different types of treatment of non traumatic chronic subdural haematoma in paediatric age group in within one year. (time frame: one year). 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 20 Dec 2024.