UMIN-CTR Clinical Trial

Basic information
Public title	A prospective observational study of the effects of various valves on coagulation factors and platelet function after transcatheter aortic valve replacement
Acronym	A prospective observational study of the effects of various valves on coagulation factors and platelet function after transcatheter aortic valve replacement
Scientific Title	A prospective observational study of the effects of various valves on coagulation factors and platelet function after transcatheter aortic valve replacement
Scientific Title:Acronym	A prospective observational study of the effects of various valves on coagulation factors and platelet function after transcatheter aortic valve replacement
Region	Japan

Condition
Condition	Severe aortic stenosis
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the effects of various valves on coagulation factors and platelet function before and after TAVI.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	R(min)<TEG6s> [Evaluation of coagulation factors] MA(min)<TEG6s> [Evaluation of platelet function]
Key secondary outcomes

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	Patients diagnosed with aortic stenosis and undergoing transcatheter aortic valve implantation using The Edwards Lifesciences' SAPIEN3 or The Medtronic's Evolute-R at Teikyo University hospital
Key exclusion criteria	1) Patients who did not consent to participate in this study 2) Cases converted to open heart surgery during TAVI 3) Cases of massive bleeding during surgery 4) Perioperative Fresh frozen plasma or platelet transfusion 5) Non elective surgery 6) Cases where the planned valves were suddenly changed 7) Recognized coagulation system disorders before enrollment 8) TAVI with approaches other than Trans-Femoral 9) Cases with other severe valve diseases
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Takeyuki Middle name Last name Sajima
Organization	Teikyo University Hospital
Division name	Department of Anesthesiology
Zip code	173-8606
Address	2-11-1 Kaga, Itabashi-Ku, Tokyo
TEL	03-3964-1211
Email	sajitake0331@yahoo.co.jp

Public contact
Name of contact person	1st name Takeyuki Middle name Last name Sajima
Organization	Teikyo University Hospital
Division name	Department of Anesthesiology
Zip code	173-8606
Address	2-11-1 Kaga, Itabashi-Ku, Tokyo
TEL	03-3964-1211
Homepage URL
Email	sajitake0331@yahoo.co.jp

Sponsor
Institute	Teikyo University
Institute
Department

Funding Source
Organization	self funding
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	Teikyo University Ethical Review Board for Medical and Health Research Involving Human Subjects
Address	2-11-1 Kaga, Itabashi-Ku, Tokyo
Tel	03-3964-7256
Email	turb-office@teikyo-u.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	2021 Year 02 Month 01 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	No longer recruiting
Date of protocol fixation	2021 Year 02 Month 01 Day
Date of IRB	2021 Year 02 Month 01 Day
Anticipated trial start date	2021 Year 02 Month 01 Day
Last follow-up date	2021 Year 06 Month 30 Day
Date of closure to data entry	2021 Year 06 Month 30 Day
Date trial data considered complete	2021 Year 06 Month 30 Day
Date analysis concluded	2021 Year 08 Month 31 Day

Other
Other related information	We compare the effects of various valves (The Edwards Lifesciences' SAPIEN3 or The Medtronic's Evolute-R) on coagulation factors and platelet function before and after TAVI.

Management information
Registered date	2021 Year 02 Month 01 Day
Last modified on	2021 Year 08 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000048479