臨床研究等提出・公開システム

Hemostasis using Novel Synthetic Peptides for Gastrointestinal Bleeding in Malignant Tumors: A Multicenter Prospective Study

PURE study

Imai Kenichiro

Shizuoka Cancer Center

1007Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka

ke.imai@scchr.jp

Imai Kenichiro

Shizuoka Cancer Center

1007Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka

+81-55-989-5222

ke.imai@scchr.jp

Recruiting

July. 05, 2023

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

(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

(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

Both

Patients with suspected gastrointestinal bleeding due to malignancy

PuraStat is applied to the bleeding site of malignant tumors using a transendoscopically inserted sheath catheter.

Rate of successful hemostasis of bleeding from malignant tumors

(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

+81-55-989-5222

May. 25, 2023

No

none