Evaluation of One Burr Hole Evacuation for Subdural Hematoma

To evaluate the outcome of one burrhole evacuation for subdural hematoma and it has the same result of traditional two burrhole

Study Overview

• Status: Not yet recruiting
• Conditions: Subdural Hematoma
• Intervention / Treatment: Procedure: Evacuation for subdural hematoma by one 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

• Study Type: Observational
• Enrollment (Estimated): 35

Contacts and Locations

• Study Contact: Name: Mohammed Lotfi, Resident; Phone Number: 01147341661; Email: Mohammedlotfi029@gmail.com
• Study Contact Backup: Name: Ahmed Abo kresha, Professor; Phone Number: +201006814906

Study Locations

• Egypt
  • Assiut, Egypt, 71515
    • Mohammed lotfi abdelkareem
    • Contact: Mohammed Lotfi
  • Malawi
    • Minya, Malawi, Egypt, 61631
      • Mohammed lotfi abdelkareem
      • Contact: Mohammed Lotfi a, Reseddnt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Both sex Adult obove 18 years old

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ClinicalEvaluation of evacuation for subdural hematoma by one burrhole	glasgo coma scale,; neurological deficit,; clinical symptoms (seizures) .	72 hours post operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiological evaluation for outcome	Nearly gross total evacuation according to confirmation by postoperative CT brain	72 hours post operative

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: Shady Hassaan, Lecturer of Neurosurgery

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: October 10, 2023
• First Submitted That Met QC Criteria: November 5, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 5, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Hemorrhage; Craniocerebral Trauma; Trauma, Nervous System; Intracranial Hemorrhages; Intracranial Hemorrhage, Traumatic; Hematoma; Hematoma, Subdural
• Other Study ID Numbers: Subdural hematoma

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No