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NCT Number: NCT06743893

Non Traumatic Chronic Subdural Haematoma in Paediatric Age Groups, Management and Outcome

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

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Key information

Age range

1 hour–18 year

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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Treatment and study plan

Diagnosis and outcome of non traumatic chronic subdural haematoma in pediatric age groups

Other

Diagnosis and outcome of non traumatic chronic subdural haematoma in pediatric age groups

Primary outcomes

  1. 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.

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

    Time frame: one year

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Abdelrahaman Abobakr Abass, Bachelor of medicine degree

CONTACT

[email protected]

0020882132478

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 20, 2024
Registry last updated
Dec 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.