NCT03447327

Brief Summary

Aim of the work: Is to evaluate the prognosis of single burr hole under local anesthesia in management of CSDH according to clinical picture, risk factors, and age.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2014

Status
completed

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

Study Start

First participant enrolled

March 5, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2015

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

February 20, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 27, 2018

Completed
Last Updated

February 27, 2018

Status Verified

February 1, 2018

Enrollment Period

12 months

First QC Date

February 20, 2018

Last Update Submit

February 25, 2018

Conditions

Chronic Subdural Hematoma

Outcome Measures

Primary Outcomes (1)

  • Glasgow Outcome Scale

    The Glasgow Outcome Scale was used as measuremabilityent for neurological oucome after surgery.The patients were classified as as dead, persistant vegetative state, severe disability, moderate disability, and mild dis

    6 months postoperative

Study Arms (1)

operated group

OTHER

patients undergoing surgery for chronic subdural hematoma by single burr hole under local anaesthesia

Procedure: single burr hole

Interventions

single burr holePROCEDURE

patients with CSDH operated by single burr hole craniostomy under local anaesthesia

operated group

Eligibility Criteria

Age19 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hematoma, Subdural, Chronic

Interventions

Trephining

Condition Hierarchy (Ancestors)

Hematoma, SubduralIntracranial Hemorrhage, TraumaticIntracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemVascular DiseasesCardiovascular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHematomaHemorrhageWounds and Injuries

Intervention Hierarchy (Ancestors)

CraniotomyNeurosurgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

February 20, 2018

First Posted

February 27, 2018

Study Start

March 5, 2014

Primary Completion

February 28, 2015

Study Completion

August 28, 2015

Last Updated

February 27, 2018

Record last verified: 2018-02