PURE study

JRCT ID: jRCTs042230057

Registered date:05/07/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients with suspected gastrointestinal bleeding due to malignancy
• Date of first enrollment: 02/08/2023
• Target sample size: 30
• Study type: Interventional
• Intervention(s): PuraStat is applied to the bleeding site of malignant tumors using a transendoscopically inserted sheath catheter.

Outcome(s)

• Primary Outcome: Rate of successful hemostasis of bleeding from malignant tumors

Secondary Outcome

(1) Success rate of immediate hemostasis
(2) Rebleeding rate (3days, 4 weeks, 12 weeks)
(3) Rate of adverse events (All study period)
(4) Amount of PuraStat used
(5) Effective hemostatic cases
(6) Survival during the study period
(7) PS
(8) survival duration during the study period

Key inclusion & exclusion criteria

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

Include criteria

(1)Patients with suspected gastrointestinal bleeding due to malignancy
(2)ECOG performance status (PS) 0-3
(3)Patients who received a transfusion of red blood cell products within 1 week prior to enrollment or had a hemoglobin level of less than 8.0 g/dl on blood test within 1 week prior to enrollment

Exclude criteria

(1) Cases with disorders of coagulation dysfunction
(2) Cases with uncontrolled infectious disease
(3) Patients with a history of hypersensitivity to peptide formulations or protein formulations
(4) Other cases in which the principal investigator or subinvestigator determines that the subject is unsuitable for the study

Related Information

• Primary Sponsor: Imai Kenichiro
• Source(s) of Monetary Support: 3-D Matrix, Ltd.