UMIN-CTR Clinical Trial

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