Study on the Efficacy of Long-term Drainage of Subdural Effusion After Decompressive Craniectomy

Launched by RENJI HOSPITAL · Apr 25, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how effective and safe it is to drain fluid buildup (called subdural effusion) from the brain for a longer time compared to a shorter time in patients who have had surgery (decompressive craniectomy) after a traumatic brain injury (TBI). The researchers want to find out the best way to help patients who aren’t improving with standard treatments.

To be part of this study, participants must have had surgery for a brain injury and developed this fluid buildup within 30 days after the surgery. They should also be experiencing ongoing issues with the fluid that hasn’t gotten better with regular treatments. The trial is not yet recruiting participants, and anyone interested will need to sign an informed consent form. It’s important to note that some people, like those with a history of certain brain problems or infections, will not be eligible to join. If you or a loved one is considering participating, the study will provide details on what to expect throughout the process.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Unilateral DC surgery was performed on TBI patients after injury;
• • 2. Subdural effusion occurred for the first time and occurred within 30 days after DC surgery;
• • 3. Unilateral effusion accumulation (can appear on the same or opposite side of the bone flap);
• • 4. The subdural effusion cannot be absorbed or has no decreasing trend with conservative treatment and consistent with the indications for surgical treatment;
• • 5. Sign the study informed consent;
• Exclusion Criteria:
• • 1. History of craniocerebral disease or craniocerebral surgery;
• • 2. Patients with intracranial infection (cerebrospinal fluid test results must be confirmed by lumbar puncture before inclusion);
• • 3. Combined with ventricular hydrocephalus;
• • 4. Other factors lead to poor prognosis or affect the treatment plan of the patient, even if the effusion can be recovered well, but severe pre-existing disability or severe co-morbidity such as serious heart disease leads to poor prognosis or even death;
• • 5. Pregnant female.