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Not yet recruitingNCT06119932Updated Nov 7, 2023

Evaluation of One Burr Hole Evacuation for Subdural Hematoma

An observational study in Subdural Hematoma, sponsored by Assiut University. Not yet recruiting at 2 sites in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-07.

Sponsored by Assiut University · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2024, 2 years 4 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
35
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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
02

Conditions studied

  • Subdural Hematoma

Browse trials for

03

In context

Hematoma, Subdural

44 studies on the registry are indexed under Hematoma, Subdural; 15 are open to participants now.

This study's planned enrollment of 35 is below the median of 167 across 11 observational studies indexed under Hematoma, Subdural.

Browse Hematoma, Subdural studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Both sex Adult obove 18 years old

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Patients unfit for surgery
  • Acute SDH
  • subdural hyroma
  • subdural empyema
  • patient treated conservatively
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
35 participants (estimated)
Patient registry
No

Interventions

  • ProcedureEvacuation for subdural hematoma by one burrhole

    Evacuation for subdural hematoma by one burrhole

06

What researchers measure

Primary outcomes

  1. ClinicalEvaluation of evacuation for subdural hematoma by one burrhole

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

    Time frame: 72 hours post operative

Secondary outcomes

  1. Radiological evaluation for outcome

    Nearly gross total evacuation according to confirmation by postoperative CT brain

    Time frame: 72 hours post operative

07

Study locations

2 sites
  • Mohammed lotfi abdelkareem
    Minya, Malawi 61631, Egypt
    • Mohammed Lotfi a, Reseddnt · Contact
  • Mohammed lotfi abdelkareem
    Assiut, 71515, Egypt
    • Mohammed Lotfi · Contact
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06119932
Lead sponsor
Assiut University
Responsible party
Mohammed lotfi abdelkareem (Neurosurgical resident, Assiut University) — Principal investigator
First posted
Nov 7, 2023
Start date
Nov 1, 2023 (estimated)
Primary completion
Jul 1, 2024 (estimated)
Completion
Oct 1, 2024 (estimated)
Last update
Nov 7, 2023

Study contacts

Mohammed Lotfi, Resident
Contact
Mohammedlotfi029@gmail.com
01147341661
Ahmed Abo kresha, Professor
Contact
+201006814906
Shady Hassaan
study director · Lecturer of Neurosurgery

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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