colon polyps of patients who have non valvular atrial fibrillation and use warfarin for the prevention of thrombosis
Conditions
Interventions
In patients who have non valvular atrial fibrillation and use warfarin for prevention of thrombosis, colorectal polypectomy/EMR wil be performed without cessation of warfarin. Protocol treatment per
Sponsors
The University of Tokyo Hospital Department of Gastroenterology, Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with non valvular atrial fibrillation, and use warfarin for prevention of thrombosis. Patients' PS (Performance Status) is 0-2 of ECOG(Eastern Cooperative Oncology Group), and over 20 years old age. The target is colorectal polyp that is indicated in polypectomy or EMR in Japanese colon polyp practice guidelines 2014. (1)In blood collection within 3days before the treatment, PT-INR has to be confirmed following values. Less than 70 years of age:PT-INR is less than 3 70 years of age or older: PT-INR is less than 2.6 (2)CCr is confirmed greater than or equal to 50mL/min(Cockcroft-Gault Equation) at the day before treatment. (3)After the patient himself has received a sufficient explanation on participation in this study, informed consent has been obtained by the free will of the patient him or herself. (4)It is possible to follow the course of more than 28 days after treatment. (5)All the following test data using the latest test values within 30 days prior to registration is met. a)Hb is 9g/dl or more b)Plt is 100000/mm3 or more c)AST, ALT is less than 100IU/L d)APTT is less than 40sec
Exclusion criteria
Exclusion criteria: (1)CCr is less continuously 50mL/min (Cockcroft-Gault Equation) (2)Woman who has a possibility of pregnancy or is during pregnancy (3)Woman who nurses her baby (4)Patients who undergo hemodialysis (5)To assess the general condition and complications of patients, if the attending physician has determined that it is difficult to entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The bleeding rate after polypectomy/EMR from immediately to the 28th day after polypectomy/EMR. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Early bleeding rate after polypectomy/EMR (from immediately after polypectomy/EMR to before the day2 meal starts) 2. Delayed bleeding rate after polypectomy/EMR (after the day2 meal has started) 3.Bleeding rate after polypectomy/EMR by the the tumor site and the major axis of tumor 4.The rate and number of blood transfusion for the bleeding during the polypectomy/EMR 5.The rate and number of blood transfusion for the bleeding after the polypectomy/EMR 6.PT-INR at the time of bleeding after polypectomy/EMR 7.Complications and the bleeding rate after polypectomy/EMR 8.Length of hospitalization | — |
Countries
Japan
Contacts
Public ContactItaru Saito
The University of Tokyo Hospital Department of Gastroenterology, Graduate School of Medicine
Outcome results
None listed