Clinical trial NCT06119932: Evaluation of One Burr Hole Evacuation for Subdural Hematoma
Official title: Evaluation of One Burr Hole Evacuation for Subdural Hematoma
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Subdural Hematoma
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Both sex Adult obove 18 years old

Brief summary: 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)
  1. Trauma; mostly minor Trauma, Approximately two thirds of The Patients have suffered one. Reports exist of chronic SDH due to birth trauma in neonates.
  2. Advanced age: The elderly are at risk due to:

     1. brain atrophy, whereby The bridging veins are stretched and become more fragile.
     2. Older People tend to fall more often and Suffer minor head trauma.
     3. With increase age, The incidence of blood Thinner administration raises leading to increased risk for haemorrhage
  3. Chronic alcoholism:
  4. Gender: men, from all age groups, suffer higher rates of chsDH than woman.
  5. CoagulaPathy: Therapeutic anticoagulation and antiplatelet therapy.
  6. Medical Conditions: sepsis, hepatic failure, hemophilia, DIC and renal dialysis.
  7. 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)

  1. Conservative: A watch, wait and re-scan Policy is usually recommended in asymptomatic or minimally symptomatic patient with a thin CHSDH.
  2. 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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Patients unfit for surgery
* Acute SDH
* subdural hyroma
* subdural empyema
* patient treated conservatively

Primary outcomes:
measure: ClinicalEvaluation of evacuation for subdural hematoma by one burrhole
timeFrame: 72 hours post operative
Secondary outcomes:
measure: Radiological evaluation for outcome
timeFrame: 72 hours post operative
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Mohammed lotfi abdelkareem
state: Malawi
city: Assiut
country: Egypt
facility: Mohammed lotfi abdelkareem
Study officials:
affiliation: Lecturer of Neurosurgery
name: Shady Hassaan
role: STUDY_DIRECTOR
References: