VER-01 Hemostasis in Cardiovascular Surgery Study

JRCT ID: jRCT2031230363

Registered date:27/09/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Subject undergoing elective, open, revascularization surgery such as bypass grafting and replacement
• Date of first enrollment: 01/10/2023
• Target sample size: 160
• Study type: Interventional
• Intervention(s): Subjects, who are undergoing elective, open, revascularization surgery such as bypass grafting and replacement of vascular prostheses for coronary artery, aorta (including thorax and abdominal) and peripheral artery and arteriovenous shunt procedure, required an adjunctive hemostat on the anastomosis determined by principal investigators and sub-investigators are enrolled and randomized to VER-01 or Beriplast P in a 1:1 allocation ratio, and VER-01 or Beriplast P will be applied to the enrolled subjects.

Outcome(s)

• Primary Outcome: The success rate of hemostasis at 5 minutes following treatment application and with no re-bleeding requiring treatment at the TBS any time prior to initiation of final chest wall closure.

Key inclusion & exclusion criteria

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

Include criteria

Pre-operative
1.Subject undergoing elective, open, revascularization surgery such as bypass grafting and replacement of vascular prostheses for coronary artery, aorta (including thoracic and abdominal) and peripheral artery and arteriovenous shunt procedure.
2.At least 18 years of age at the time of informed consent.
3.Willingness to comply with the protocol.
4.Willingness to give consent before all study-related activities.

Intra-operative
1.Target bleeding site (mild and moderate bleeding) is identified, and requires adjunctive hemostasis determined by principal investigators and sub-investigators.

Exclude criteria

Pre-operative
1.Subjects with serious hepatic impairment (Either AST(GOT) or ALT(GPT) > 5 times the upper limit of site reference value).
2.Subjects suspected of having disseminated intravascular coagulation (DIC) (e.g., sepsis, acute leukemia, solid tumors).
3.Subjects who have intolerance to any of the components of the investigational or comparator products (including bovine-derived ingredients).
4.Subjects who are not willing to use blood products.
5.Subjects with immunodeficiency or undergoing treatment for immunodepression.
6.Subjects with hemolyzing property or blood loss anemia.
7.Subjects of childbearing potential with a positive pregnancy test or intent to become pregnant during the clinical study period.
8.Subjects who are breastfeeding.
9.Subjects who have participated in or will participate in another clinical trial of another a test drug/device within 30 days before and after a surgery of the clinical trial.
10.Subjects judged to be inappropriate by the principal investigator or sub-investigator.

Intra-operative
1.Subjects bleeding from only parenchyma tissue.
2.Subjects with an actively infected field of potential target bleeding site
3.Subjects who have serious complication in surgeries requiring emergency resuscitation or changing of planned surgeries.
4.Subjects judged to be inappropriate by the principal investigator or sub-investigators.

Related Information

• Primary Sponsor: Deura Imari