Study on the Efficacy of Long-term Drainage of Subdural Effusion After Decompressive Craniectomy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorRenJi Hospital
About this trial
Drilling or puncture drainage is commonly used in TBI patients with subdural effusion following decompressive craniectomy who fail to respond to conservative treatment, but there is no exact regulation or guideline recommendation for the drainage time. The investigators aimed to conduct a randomized controlled trial to evaluate the efficacy and safety of long-term versus short-term drainage in the treatment of subdural effusion after decompressive craniectomy in patients with traumatic brain injury.
Eligibility criteria
Qualifiers
Unilateral DC surgery was performed on TBI patients after injury;
Subdural effusion occurred for the first time and occurred within 30 days after DC surgery;
Unilateral effusion accumulation (can appear on the same or opposite side of the bone flap);
The subdural effusion cannot be absorbed or has no decreasing trend with conservative treatment and consistent with the indications for surgical treatment;
Disqualifiers
History of craniocerebral disease or craniocerebral surgery;
Patients with intracranial infection (cerebrospinal fluid test results must be confirmed by lumbar puncture before inclusion);
Combined with ventricular hydrocephalus;
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;
Trial design
Treatments tested in this trial
- Long-term Drainage
- Short-term Drainage
Treatment groups
160 Participants
are divided into 2 treatment groupsSponsors and collaborators
RenJi Hospital
Lead sponsor
Zhujiang Hospital
Collaborator
Clinical Research Institute, Shanghai Jiao Tong University School of Medicine
Collaborator
Source ClinicalTrials.gov