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The Three-drug Medication Therapy for Chronic Subdural Hematoma

Multicentre, Randomised, Parallel-Group Comparative Trial on the Recurrence Prevention Efficacy and Safety of Triple Combination Therapy for Chronic Subdural Haematoma Post-Surgery - Triple Study

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031240007
Enrollment
180
Registered
2024-04-03
Start date
2024-05-01
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

Patients who were first diagnosed with chronic subdural hematoma and after burr hole surgery.

Interventions

Goreisan and carbazochrome sodium sulfonate hydrate and tranexamic aid were administered orally thrice daily to patients within at least 72 hours after surgery.

Sponsors

Hirata Koji
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 18 years or more 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 legal proxy

Exclusion criteria

Exclusion 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. Patients who have already received any of the study drugs 6. Those with hereditary fructose intolerance 7.Those in the acute phase of ischemic vascular disease 8. Patients with deep vein thrombosis 9. Patients under consumption coagulopathy or disseminated intravascular coagulation 10. Patients with thrombotic predisposition 11.Those 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 which the physician deems unsuitable for enrollment in this study

Design outcomes

Primary

MeasureTime frame
the recurrence rate of hematoma.

Secondary

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

Contacts

Public ContactKoji Hirata

University of Tsukuba Hospital

hirata.koji.fp@ms.hosp.tsukuba.ac.jp+81-29-853-3220

Outcome results

None listed

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