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

Официальное название

A Randomised Controlled Trial to Evaluate Long-term Drainage for Patients Undergoing Decompressive Craniectomy With the Complication of Subdural Diffusion

Обзор

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.

Подробное описание

Subdural effusion is a common complication following decompressive craniectomy for TBI (traumatic brain injury), with an overall incidence of 20%-50%. The clinical symptoms of subdural effusion are mainly related to the volume of effusion, and patients with a small volume of effusion may have no obvious symptoms. The flap bulge and tension of the decompression window can be seen on the same side of the decompressive craniectomy window. The specific clinical manifestations can include headache, dizziness, vomiting, epilepsy, hemiplegia, disturbance of consciousness, and other related symptoms. The degree of disturbance of consciousness changes, which can seriously affect the prognosis of patients. Drilling or puncture drainage is often used in patients with subdural effusion who fail to treat conservatively, but the drainage time has not been defined or recommended by guidelines. At present, short-term drainage is the main treatment, but there are problems such as difficulty completely absorbing the effusion or repeated recurrence. Long-term drainage can improve the absorption rate of effusion, but there is a risk of intracranial infection and other complications. Therefore, it is rarely used in clinical practice, and its clinical risks and benefits are not yet clear. Therefore, the investigators aimed to conduct a randomized controlled trial to evaluate the efficacy and safety of long-term drainage and short-term drainage in the treatment of subdural effusion after decompressive craniectomy in patients with traumatic brain injury.

Вмешательства

• Процедура Long-term Drainage
  After drilling or puncture, the drainage catheter is indwelling continuously and keeps to drainage for 7 days. Keep incision sterility, record the daily fluid drainage flow, and perform biochemical and bacterial culture identification tests for CSF regularly. Removing drainage catheter when the allocated time is reached. If there is still unabsorbed effusion after the allocated time is reached, the catheter placement time is extended and the relevant information is recorded.
• Процедура Short-term Drainage
  After drilling or puncture, the drainage catheter is indwelling continuously and keeps to drainage for 2 days. Keep incision sterility, record the daily fluid drainage flow, and perform biochemical and bacterial culture identification tests for CSF regularly. Removing drainage catheter when the allocated time is reached. If there is still unabsorbed effusion after the allocated time is reached, the catheter placement time is extended and the relevant information is recorded.

Первичные конечные точки

• Recurrence rate of subdural effusion 1 month after drainage catheter removal. [Срок оценки: 1 month after drainage catheter removal.]

Вторичные конечные точки (4)

• Incidence of related complications. [Срок оценки: 1 month after drainage catheter removal.]
• Method of re-intervention after recurrence of effusion. [Срок оценки: 1 month after drainage catheter removal.]
• Length of stay in hospital and detailed economic evaluation. [Срок оценки: 1 month after drainage catheter removal.]
• GOSE (extended Glasgow Outcome Scale) scores. [Срок оценки: 1, 3 and 6 months after drainage catheter removal.]

Критерии участия

Критерии включения

• 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;
• Sign the study informed consent;

Критерии исключения

• 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;
• Pregnant female.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Brain Injury Center, Renji Hospital, School of Medicine, Shanghai Jiao Tong University — Шанхай

Идентификаторы

NCT: NCT06391203 · DRAINAGE

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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