Unique ID issued by UMIN | UMIN000018682 |
---|---|
Receipt number | R000015796 |
Scientific Title | A randomized controlled trial for validity of aspirin continuation in the preoperative period of intra-peritoneal surgery |
Date of disclosure of the study information | 2015/08/14 |
Last modified on | 2015/08/14 19:43:25 |
A randomized controlled trial for validity of aspirin continuation in the preoperative period of intra-peritoneal
surgery
ACTIVE surgery trial
A randomized controlled trial for validity of aspirin continuation in the preoperative period of intra-peritoneal
surgery
ACTIVE surgery trial
Japan |
The patients who need gastroenterological surgery and were treated with prophylactic aspirin due to cardiovascular events
Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Malignancy
NO
To verify non-inferiority of blood loss under peri-operative aspirin use during gastroenterological surgery.
Safety
operative blood loss
Adverse events with peri-operative hemorrhage, transfusion rate, re-operation rate, hospital stay, cardio-vasuluar/cardio-cerebrovascular events, delta hemoglobin
Interventional
Parallel
Randomized
Open -no one is blinded
Active
2
Treatment
Medicine |
aspirin continuation
withdraw aspirin (alternative heparin)
20 | years-old | <= |
Not applicable |
Male and Female
(1) open- or laparoscopic- cholecystectomy, gastorectomy, or colo-rectal surgery.
(2) more than 3 months aspirin use
(3) PS 0-2
(4) written informed consent
(1) platelets < 15x10^4/uL
(2) active or possible bleeding
(3) active infection
(4) anti-coagulant use
(5) necessary of anti-coagulant for perioperative VTE prophylaxis
(6) contraindication of intermittent pneumatic compression for VTE
(7) severe complications (e.g. hepatic failure, uncontrollable hypertension, bronchial asthma)
(8) allergy for aspirin or heparin
(9) history of brain surgery
(10) history of MI or angina
(11) scheduled other surgery
(12) pregnancy
(13) mental disorder
(14) others
300
1st name | |
Middle name | |
Last name | Toshinori Itoh |
Osaka University
Department of Complementary and Alternative Medicine
Yamadaoka 2-2, Suita, Osaka
06-6879-3251
s-kobayashi@umin.ac.jp
1st name | |
Middle name | |
Last name | Shogo Kobayashi |
Osaka University
Department of Surgery
Yamadaoka 2-2, Suita, Osaka
06-6879-3251
s-kobayashi@umin.ac.jp
Clinical Study Group of Osaka University,
Risk Management Group
Clinical Study Group of Osaka University
Self funding
NO
2015 | Year | 08 | Month | 14 | Day |
Unpublished
Open public recruiting
2014 | Year | 03 | Month | 14 | Day |
2015 | Year | 08 | Month | 05 | Day |
2015 | Year | 08 | Month | 14 | Day |
2015 | Year | 08 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015796
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |