Study of procedures for removal of chronic subdural hematoma

JRCT ID: jRCT1041220124

Registered date:22/01/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: chronic subdural hematoma
• Date of first enrollment: 31/01/2023
• Target sample size: 1186
• Study type: Interventional

Intervention(s)

In order to evaluate the effectiveness of irrigation subsequent to the evacuation of chronic subdural hematoma utilizing artificial spinal fluid (ARTCEREB Irrigation and Perfusion Solution for Cerebrospinal Surgery), the intervention will be divided into two groups: the hematoma irrigation group and the non-irrigation group.

The hematoma irrigation group: Following the evacuation of the hematoma via burr hole craniostomy, irrigation will be repeated until the fluid drainage is clear, with a minimum of 200ml to wash the hematoma cavity. A closed drain is then left in place for a minimum of 12 hours postoperatively.

The non-irrigation group: Following burr hole craniostomy, a drain is placed without irrigation. Similar to the hematoma irrigation group, a closed drain is left in place for a minimum of 12 hours postoperatively.

Outcome(s)

• Primary Outcome: Patients who fulfill the criteria for revision surgery on the ipsilateral side within six months following initial chronic subdural hematoma surgery (Including patients who were deemed by the physician to require reoperation but were not actually operated on).

Secondary Outcome

(1) Individuals who underwent actual reoperation within six months following initial surgery
(2) Reoperation rate within six months postoperatively for each preoperative hematoma shape (ipsilateral)
(3) Alterations in mRS, GCS, and Markwalder classification after six months
(4) Mortality rate within six months following surgery
(5) Length of time from surgery to discharge (including recovery ward)
(6) Duration of surgical procedure transfer
(7) Surgical-related complications

Key inclusion & exclusion criteria

• Age minimum: > 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

-Patients with symptomatic chronic subdural hematoma requiring a surgical procedure
-20 years of age or older
-Patients undergoing surgery for a single-side CSDH
-Patients who have obtained written informed consent from the patient or an authorized representative

Exclude criteria

-Patients who have previously received an ipsilateral craniostomy
-Patients who have previously undergone a craniotomy
-Patients who have previously undergone cerebrospinal fluid shunting
-Patients with intracranial mass lesions that may impact current symptoms, excluding very small tumors or contralateral hematoma, etc.
-Participants who have received radiation or chemotherapy within the past five years.
-Patients with immunocompromised status
-Patients at risk of thrombosis severe enough to not tolerate discontinuation of antithrombotic medications, such as recent cardiac or intracranial stents, recent pulmonary embolism, or artificial heart valve
-Inability of the patient to cooperate or preoperatively determined that the hematoma is so small that a drain cannot be inserted
-Patients who, in the judgment of the investigator, are likely to be non-compliant or uncooperative during the study.

Related Information

• Primary Sponsor: Saito Ryuta
• Source(s) of Monetary Support: Nagoya University, Graduate School of Medicine.,THE JAPAN SOCIETY OF NEUROTRAUMATOLOGY