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Clinical Trials/NCT06119932
NCT06119932Not yet recruitingNot Applicable

Evaluation of One Burr Hole Evacuation for Subdural Hematoma

Assiut University1 site in 1 country35 target enrollmentStarted: November 1, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
35
Locations
1
Primary Endpoint
ClinicalEvaluation of evacuation for subdural hematoma by one burrhole

Study Overview

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:

  3. brain atrophy, whereby The bridging veins are stretched and become more fragile.

  4. Older People tend to fall more often and Suffer minor head trauma.

  5. With increase age, The incidence of blood Thinner administration raises leading to increased risk for haemorrhage

  6. Chronic alcoholism:

  7. Gender: men, from all age groups, suffer higher rates of chsDH than woman.

  8. CoagulaPathy: Therapeutic anticoagulation and antiplatelet therapy.

  9. Medical Conditions: sepsis, hepatic failure, hemophilia, DIC and renal dialysis.

  10. 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)

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

ClinicalEvaluation of evacuation for subdural hematoma by one burrhole

Time Frame: 72 hours post operative

* glasgo coma scale, * neurological deficit, * clinical symptoms (seizures) .

Secondary Outcomes

  • Radiological evaluation for outcome(72 hours post operative)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mohammed lotfi abdelkareem

Neurosurgical resident

Assiut University

Study Sites (1)

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