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Tests treatment safety and results for Chronic Subdural Hematoma
Official title The Effectiveness and Safety of Body Posture in Preventing Postoperative Recurrence for Chronic Subdural Hematoma
ClinicalTrials.gov ID: NCT06401772
What this study is testing
- What it's testing
- This study aims to investigate the effectiveness and safety of body posture to improve intracranial pressure in preventing postoperative recurrence for chronic subdural hematoma
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older
You may be able to join if
- chronic subdural hematoma is diagnosed with CT/MRI scan; thickness of hematoma is more than 1 cm;
- more than 60 years of age or 60 years;
- MGS-GCS (Markwalder's Grading Scale and Glasgow Coma Scale) is less than or equal to 2;
- patients have neurological symptom caused by CSDH before surgery, such as headache, dizziness, nausea, vomiting, numbness or weakness of limb...
- receive burr hole drainage;
You likely can't join if
- have brain hernia or acute massive cerebral infarction that have to perform craniotomy
- have severe malignancies, hemorrhagic disease, cardiac dysfunction and other serious disease that may impede recovery or follow-up compliance;
- Spinal deformities (e.g., kyphosis) or psychiatric disorders precluding prolonged body posture therapy adherence
- Concomitant severe intracranial tumors, aneurysms, or vascular malformations that may impede recovery.
- Patients with cranial CT demonstrating no significant compression or displacement of brain tissue, asymptomatic presentation, and unaffected daily...
- CSDH persisting for over 1 year and exhibiting marked organization/solidification of the hematoma;
See the full eligibility criteria
- chronic subdural hematoma is diagnosed with CT/MRI scan; thickness of hematoma is more than 1 cm;
- more than 60 years of age or 60 years;
- MGS-GCS (Markwalder's Grading Scale and Glasgow Coma Scale) is less than or equal to 2;
- patients have neurological symptom caused by CSDH before surgery, such as headache, dizziness, nausea, vomiting, numbness or weakness of limb, instability to walk, unconsciousness, trouble speaking, insensitive, etc.
- receive burr hole drainage;
- sign informed consent voluntarily.
- have brain hernia or acute massive cerebral infarction that have to perform craniotomy
- have severe malignancies, hemorrhagic disease, cardiac dysfunction and other serious disease that may impede recovery or follow-up compliance;
- Spinal deformities (e.g., kyphosis) or psychiatric disorders precluding prolonged body posture therapy adherence
- Concomitant severe intracranial tumors, aneurysms, or vascular malformations that may impede recovery.
- Patients with cranial CT demonstrating no significant compression or displacement of brain tissue, asymptomatic presentation, and unaffected daily activities were deemed ineligible for surgical intervention by...
- CSDH persisting for over 1 year and exhibiting marked organization/solidification of the hematoma;
- CSDH caused by over V-P shunting;
- during burr hole drainage, patients have to perform craniotomy due to acute bleeding or brain hernia;
- Intraoperative complications (e.g., cerebral contusion, intraparenchymal catheter placement) during burr hole drainage;
- have deep venous thrombosis of lower extremity or pulmonary embolism;
- cannot complete regular reexamine within 1 year for any reason;
- life expectancy less than 1 year;
- participating other ongoing clinical trial;
- patients are not qualified for other reason evaluated by two neurosurgeons;
- have bile reflux gastritis and esophageal diseases.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.