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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000018682
Receipt No. 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

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Basic information
Public title A randomized controlled trial for validity of aspirin continuation in the preoperative period of intra-peritoneal
surgery
Acronym ACTIVE surgery trial
Scientific Title A randomized controlled trial for validity of aspirin continuation in the preoperative period of intra-peritoneal
surgery
Scientific Title:Acronym ACTIVE surgery trial
Region
Japan

Condition
Condition The patients who need gastroenterological surgery and were treated with prophylactic aspirin due to cardiovascular events
Classification by specialty
Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To verify non-inferiority of blood loss under peri-operative aspirin use during gastroenterological surgery.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes operative blood loss
Key secondary outcomes Adverse events with peri-operative hemorrhage, transfusion rate, re-operation rate, hospital stay, cardio-vasuluar/cardio-cerebrovascular events, delta hemoglobin

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 aspirin continuation
Interventions/Control_2 withdraw aspirin (alternative heparin)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (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
Key exclusion criteria (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
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshinori Itoh
Organization Osaka University
Division name Department of Complementary and Alternative Medicine
Zip code
Address Yamadaoka 2-2, Suita, Osaka
TEL 06-6879-3251
Email s-kobayashi@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shogo Kobayashi
Organization Osaka University
Division name Department of Surgery
Zip code
Address Yamadaoka 2-2, Suita, Osaka
TEL 06-6879-3251
Homepage URL
Email s-kobayashi@umin.ac.jp

Sponsor
Institute Clinical Study Group of Osaka University,
Risk Management Group
Institute
Department

Funding Source
Organization Clinical Study Group of Osaka University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2015 Year 08 Month 14 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2014 Year 03 Month 14 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 08 Month 14 Day
Last modified on
2015 Year 08 Month 14 Day


Link to view the page
URL(English) https://upload.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


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