PURE study
Phase 2
Recruiting
- Conditions
- Patients with suspected gastrointestinal bleeding due to malignancy
- Registration Number
- JPRN-jRCTs042230057
- Lead Sponsor
- Imai Kenichiro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
Inclusion 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
Exclusion 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of successful hemostasis of bleeding from malignant tumors
- Secondary Outcome Measures
Name Time Method (1) Success rate of immediate hemostasis<br>(2) Rebleeding rate (3days, 4 weeks, 12 weeks)<br>(3) Rate of adverse events (All study period)<br>(4) Amount of PuraStat used<br>(5) Effective hemostatic cases<br>(6) Survival during the study period<br>(7) PS<br>(8) survival duration during the study period