The Three-drug Medication Therapy for Chronic Subdural Hematoma

JRCT ID: jRCTs031240007

Registered date:03/04/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients who were first diagnosed with chronic subdural hematoma and after burr hole surgery.
• Date of first enrollment: 01/05/2024
• Target sample size: 180
• Study type: Interventional
• Intervention(s): Goreisan and carbazochrome sodium sulfonate hydrate and tranexamic aid were administered orally thrice daily to patients within at least 72 hours after surgery.

Outcome(s)

• Primary Outcome: the recurrence rate of hematoma.

Secondary Outcome

1. the duration of recurrence
2. hematoma volume on CT at 1day, 10days, 30days, 60days and 90days after surgery.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.aged at 18 years or over
2.first diagnosed with chronic subdural hematoma
3.allocation within 72 hours after surgery
4.no plan for embolization to the middle meningeal artery
5.Written consent has been obtained from the individual or a surrogate

Exclude criteria

1.after craniotomy or embolization of middle meningeal artery
2.recurrence of chronic subdural hematoma
3.Patients with cerebrospinal fluid shunt
4.Patients with a history of hypersensitivity to any component of the study drug
5.those drugs had already been used
6.with hereditary fructose intolerance
7.On acute phase of ischemic vascular disease
8.patients with deep vein thrombosis
9.patients under consumption coagulopathy or disseminated intravascular coagulation
10.with thrombotic predisposition
11.on dialysis
12.Pregnant women
13.Patients who have received other study or investigational drugs for therapeutic purposes within three months of the scheduled administration of the study drug
14.Other patients in which the physician deems the applicant unsuitable for enrollment in this study

Related Information

• Primary Sponsor: Hirata Koji
• Source(s) of Monetary Support: University of Tsukuba Hospital