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

NCT ID: NCT06743893

Last Updated: 2024-12-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-12-15
• Study Completion Date: 2025-12-15

Brief 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

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:

1. Inclusion criteria:

1-Age less than 18 years. 2-patient with subdural haematoma other than traumatic

2. 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.

3. 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

Conditions

Chronic Non-Traumatic Intracranial Subdural Haemorrhage

Keywords

chronic- subdural haematoma- non traumatic-pediatric age group

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

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

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

Intervention Type: OTHER

Eligibility Criteria

Exclusion Criteria

-

• Minimum Eligible Age: 1 Hour
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

abo bakr mitwally

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Abdelrahaman Abobakr Abass, Bachelor of medicine degree

Role: CONTACT

Phone: 0020882132478

Email: abdelrahman1615@med.aun.edu.eg

Other Identifiers

NTCSDH

Identifier Type: -

Identifier Source: org_study_id