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Study of procedures for removal of chronic subdural hematoma

Study of Chronic Subdural Hematoma Removal With or Without Intraoperative Irrigation

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1041220124
Enrollment
1186
Registered
2023-01-22
Start date
2023-01-31
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic subdural hematoma chronic subdural hematoma, burr hole craniostomy

Interventions

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 Cerebro

Sponsors

Saito Ryuta
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
(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

Contacts

Public ContactYoshitaka Nagashima

Nagoya University, Graduate School of Medicine.

y-nagashima@med.nagoya-u.ac.jp+81-52-744-2353

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026