Evaluation of One Burr Hole Evacuation for Subdural Hematoma

Subdural Hematoma Clinical Trial

Official title:

Evaluation of One Burr Hole Evacuation for Subdural Hematoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06119932
• Other study ID #: Subdural hematoma
• Status: Not yet recruiting
• Start date: November 1, 2023
• Est. completion date: October 1, 2024

Study information

• Verified date: October 2023
• Source: Assiut University
• Contact: Mohammed Lotfi, Resident
• Phone: 01147341661
• Email: Mohammedlotfi029[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 35
• Est. completion date: October 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hematoma
• Subdural Hematoma

Intervention

Procedure:
• Evacuation for subdural hematoma by one burrhole
Evacuation for subdural hematoma by one burrhole

Locations

Country	Name	City	State
Egypt	Mohammed lotfi abdelkareem	Assiut
Egypt	Mohammed lotfi abdelkareem	Minya	Malawi

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ClinicalEvaluation of evacuation for subdural hematoma by one burrhole	glasgo coma scale,; neurological deficit,; clinical symptoms (seizures) .	72 hours post operative
Secondary	Radiological evaluation for outcome	Nearly gross total evacuation according to confirmation by postoperative CT brain	72 hours post operative