NCT06119932

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2023

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2023

Completed
22 days until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

November 7, 2023

Status Verified

October 1, 2023

Enrollment Period

8 months

First QC Date

October 10, 2023

Last Update Submit

November 5, 2023

Conditions

Subdural Hematoma

Outcome Measures

Primary Outcomes (1)

  • ClinicalEvaluation of evacuation for subdural hematoma by one burrhole

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

    72 hours post operative

Secondary Outcomes (1)

  • Radiological evaluation for outcome

    72 hours post operative

Interventions

Evacuation for subdural hematoma by one burrholePROCEDURE

Evacuation for subdural hematoma by one burrhole

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Both sex Adult obove 18 years old

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mohammed lotfi abdelkareem

Minya, Malawi, 61631, Egypt

Location

Mohammed lotfi abdelkareem

Asyut, 71515, Egypt

Location

MeSH Terms

Conditions

Hematoma, Subdural

Condition Hierarchy (Ancestors)

Intracranial Hemorrhage, TraumaticIntracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemVascular DiseasesCardiovascular DiseasesHematomaHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsWounds and Injuries

Study Officials

  • Shady Hassaan

    Lecturer of Neurosurgery

    STUDY DIRECTOR

Central Study Contacts

Mohammed Lotfi, Resident

CONTACT

01147341661Mohammedlotfi029@gmail.com

Ahmed Abo kresha, Professor

CONTACT

+201006814906

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Neurosurgical resident

Study Record Dates

First Submitted

October 10, 2023

First Posted

November 7, 2023

Study Start

November 1, 2023

Primary Completion

July 1, 2024

Study Completion

October 1, 2024

Last Updated

November 7, 2023

Record last verified: 2023-10

Locations

EG(2)