UMIN-CTR Clinical Trial

Basic information
Public title	Assessment of antithrombotic therapy before nerve or neuraxial block using thromboelastography
Acronym	Assessment of antithrombotic therapy before nerve or neuraxial block using thromboelastography
Scientific Title	Assessment of antithrombotic therapy before nerve or neuraxial block using thromboelastography
Scientific Title:Acronym	Assessment of antithrombotic therapy before nerve or neuraxial block using thromboelastography
Region	Japan

Condition
Condition	Administration or cessation of antithrombotic therapy that necessitated nerve or neuraxial block to reduce perioperative surgical pain.
Classification by specialty	Surgery in general Obsterics and gynecology Orthopedics Urology Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We assessed each thromboelastographic parameter to confirm safe and appropriate nerve or neuraxial blockade.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Reaction time, angle, kinetics, maximum amplitude, and lysis 30 min in each thromboelastography.
Key secondary outcomes	activated clotting time and morbidity.

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	100 years-old >
Gender	Male and Female
Key inclusion criteria	Administration or cessation of antithrombotic therapy that necessitated nerve or neuraxial block to reduce perioperative surgical pain.
Key exclusion criteria	hematologic disease
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Hirotsugu Middle name Last name Kanda
Organization	Asahikawa Medical University
Division name	Department of Anesthesiology and Critical Care Medicine
Zip code	078-8510
Address	Midorigaoka-higashi 2-1-1-1, Asahikawa, Hokkaido, 078-8510, Japan
TEL	0166682583
Email	hirotsugukanda0629@gmail.com

Public contact
Name of contact person	1st name Hirotsugu Middle name Last name Kanda
Organization	Asahikawa Medical University
Division name	Department of Anesthesiology and Critical Care Medicine
Zip code	078-8510
Address	Midorigaoka-higashi 2-1-1-1, Asahikawa, Hokkaido, 078-8510, Japan
TEL	0166682583
Homepage URL
Email	hirotsugukanda0629@gmail.com

Sponsor
Institute	Asahikawa Medical University
Institute
Department

Funding Source
Organization	None
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	Asahikawa Medical University Research Ethics Committee
Address	Midorigaoka-higashi 2-1-1-1, Asahikawa, Hokkaido, 078-8510, Japan
Tel	0166-68-2297
Email	rs-kk.g@asahikawa-med.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

Other administrative information
Date of disclosure of the study information	2020 Year 04 Month 13 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	21
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	Completed
Date of protocol fixation	2019 Year 05 Month 03 Day
Date of IRB	2019 Year 07 Month 05 Day
Anticipated trial start date	2020 Year 01 Month 06 Day
Last follow-up date	2022 Year 03 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Key inclusion criteria: Administration or cessation of antithrombotic therapy that necessitated nerve or neuraxial block to reduce perioperative surgical pain. Narrative objectives: We assessed each thromboelastographic parameter to confirm safe and appropriate nerve or neuraxial blockade. Primary outcomes: Reaction time, angle, kinetics, maximum amplitude, and lysis 30 min in each thromboelastography. Key secondary outcomes: activated clotting time and morbidity.

Management information
Registered date	2020 Year 04 Month 13 Day
Last modified on	2022 Year 03 Month 25 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045675