Asteria study

JRCT ID: jRCTs042230144

Registered date:05/02/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: A patient undergoing laparoscopic hepatectomy.
• Date of first enrollment: 01/03/2024
• Target sample size: 20
• Study type: Interventional
• Intervention(s): In cases where there is oozing bleeding observed on the cut surface of the liver while hemostasis cannot achieved with electrocautery, apply an appropriate amount of PuraStat 5mL to the site of oozing bleeding.

Outcome(s)

• Primary Outcome: Percentage of hemostasis achieved in 3 minutes from the start of hemostasis.

Secondary Outcome

Time to achieve hemostasis
Percentage of hemostasis achieved in 5 minutes
Percentage of hemostasis achieved in 10 minutes
Percentage of additional hemostatic treatment required
Time required for prepare PuraStat
Amount of PuraStat used
Intraoperative complications
Percentage of postoperative rebleeding
Duration of drainage
Drainage volume
Postoperative hospital stay
Adverse events within 30 days after surgery

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 laparoscopic 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. (Patients with coagulopathy or unable to withdraw antiplatelet or anticoagulant drugs)
(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 hypersensitivity to peptide or protein preparations.
(7) Patients with a history of severe hypersensitivity.
(8) Patients deemed inappropriate by the attending physician.

Related Information

• Primary Sponsor: Sugiura Teiichi