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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028321
Receipt No. R000032399
Scientific Title Evaluation of residual effect of perioperative anticoagulat and antiplatelet drugs by using Sonoclot.
Date of disclosure of the study information 2017/07/21
Last modified on 2021/08/11

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Basic information
Public title Evaluation of residual effect of perioperative anticoagulat and antiplatelet drugs by using Sonoclot.
Acronym Evaluation of residual effect of perioperative anticoagulat and antiplatelet drugs by using Sonoclot.
Scientific Title Evaluation of residual effect of perioperative anticoagulat and antiplatelet drugs by using Sonoclot.
Scientific Title:Acronym Evaluation of residual effect of perioperative anticoagulat and antiplatelet drugs by using Sonoclot.
Region
Japan

Condition
Condition Patients who are given anticoagulants or antiplatelet drugs in elective operations.
Classification by specialty
Anesthesiology Operative medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of Sonoclot when the residual inhibitory action of coagulation or platelet in case the anticoagulants or antiplatelet drugs are continued in elective operations.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes The results of Sonoclot including activated clotting time (ACT), clot rate, platelet function.
Key secondary outcomes Types of anticoagulant / antiplatelet drugs, drug holiday, presence or absence of heparin substitution, disease name, operation type, bleeding volume, blood transfusion volume.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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 Among patients undergoing anesthesia management by elective operation, patients who are continuing anticoagulant / antiplatelet drugs, patients who were discontinued, patients who have not been administered.
Key exclusion criteria Patients who can not obtain consent, emergency operation patients, patients with anemia, patients who have received transfusion within 2 weeks, patients with diagnosed blood / coagulation abnormality, patients with renal dysfunction, dialysis patients, hepatic dysfunction, patients who have stopped anticoagulant / antiplatelet drugs but who do not satisfy the drug holiday period specified in this study.
Target sample size 120

Research contact person
Name of lead principal investigator
1st name Motonobu
Middle name
Last name Kimizuka
Organization Sapporo Medical University, School of Medicine
Division name Department of Anesthesiology
Zip code 0608543
Address S.1, W.16, Chuo-ku, Sapporo, Japan
TEL 0116889663
Email m.kimizuka@sapmed.ac.jp

Public contact
Name of contact person
1st name Motonobu
Middle name
Last name Kimizuka
Organization Sapporo Medical University, School of Medicine
Division name Department of Anesthesiology
Zip code 0608543
Address S.1, W.16, Chuo-ku, Sapporo, Japan
TEL 0116889663
Homepage URL
Email m.kimizuka@sapmed.ac.jp

Sponsor
Institute Sapporo Medical University, School of Medicine, Department of Anesthesiology
Institute
Department

Funding Source
Organization Sapporo Medical University, School of Medicine, Department of Anesthesiology
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Kitami Red Cross Hospital, Hokkaido Prefectural Kitami Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization Sapporo Medical University Institutional Review Board
Address S.1, W.16, Chuo-ku, Sapporo, Japan
Tel 0116112111
Email rskk@sapmed.ac.jp

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 札幌医科大学付属病院(北海道)、北見赤十字病院(北海道)、道立北見病院(北海道)

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 21 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
2017 Year 07 Month 21 Day
Date of IRB
2021 Year 07 Month 08 Day
Anticipated trial start date
2021 Year 07 Month 28 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information After the protocol was determined, it took four years until the ethics committee to review. This is because we spent time to coordinate between hospitals due to personnel changes.

Management information
Registered date
2017 Year 07 Month 21 Day
Last modified on
2021 Year 08 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032399

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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