Oceanus OH study

JRCT ID: jRCTs042240183

Registered date:05/02/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients undergoing open hepatectomy
• Date of first enrollment: 05/02/2025
• Target sample size: 20
• Study type: Interventional
• Intervention(s): When moderate or more bleeding is persistently observed in the main hepatic vein, apply an appropriate amount of Hydrofit 2g to the bleeding site via a special sheet and compress it to stop the bleeding. If hemostasis is not obtained, hemostasis is performed again using the remaining sheet (only a maximum of one kit is used per case).

Outcome(s)

• Primary Outcome: Hemostasis achievement rate within 5 minutes from the start of hemostasis

Secondary Outcome

Time to achieve hemostasis
Percentage of hemostasis achieved after 10 minutes
Percentage of additional hemostatic treatment required
Amount of Hydrofit used
Intraoperative complications
Percentage of postoperative rebleeding
Duration of drainage
Drainage volume
Number of days of postoperative hospital stay
Postoperative adverse events within 30 days

Key inclusion & exclusion criteria

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

Include criteria

1) Age at the time of consent is older than 18 years old.
2) ECOG performance status (PS) is 0 or 1.
3) Surgical treatment is scheduled within 2 weeks of obtaining consent.
4) Scheduled for open hepatectomy.
5) Major organ functions are preserved.
6) Written informed consent has been obtained after sufficient explanation of the trial details before enrollment in this study.

Exclude criteria

(1) Patients with localized infections requiring intervention or active systemic infections.
(2) Pregnant women, nursing mother, patients with possibility of pregnant, or patients unwilling to use contraception during the study period.
(3) Patients with a history of disorders associated with coagulation abnormalities.
(4) Patients with clinically significant psychiatric disorders that would preclude enrollment in the study.
(5) Patients receiving continuous administration of steroids or immunosuppressive agents.
(6) Patients with a history of severe hypersensitivity.
(7) Patients deemed inappropriate by the attending physician.

Related Information

• Primary Sponsor: Sugiura Teiichi