Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-25 @ 7:34 PM
Study NCT ID:
NCT06119932
Status:
UNKNOWN
Last Update Posted:
2023-11-07
First Post:
2023-10-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of One Burr Hole Evacuation for Subdural Hematoma
Sponsor:
Assiut University
Organization:
Study Overview
Official Title:
Evaluation of One Burr Hole Evacuation for Subdural Hematoma
Status:
UNKNOWN
Status Verified Date:
2023-10
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the outcome of one burrhole evacuation for subdural hematoma and it has the same result of traditional two 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
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: