Patients with suspected gastrointestinal bleeding due to malignancy
Conditions
Interventions
PuraStat is applied to the bleeding site of malignant tumors using a transendoscopically inserted sheath catheter.
Sponsors
Imai Kenichiro
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of successful hemostasis of bleeding from malignant tumors | — |
Secondary
| Measure | Time frame |
|---|---|
| (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 | — |
Contacts
Public ContactKenichiro Imai
Shizuoka Cancer Center
Outcome results
None listed