UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027761
Receipt No. R000031812
Scientific Title Establishment of prediction and prevention method for bleeding complication after left ventricular assist device implantation
Date of disclosure of the study information 2017/06/14
Last modified on 2019/06/24

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Establishment of prediction and prevention method for bleeding complication after left ventricular assist device implantation
Acronym LVADAVWS Study
Scientific Title Establishment of prediction and prevention method for bleeding complication after left ventricular assist device implantation
Scientific Title:Acronym LVADAVWS Study
Region
Japan

Condition
Condition Patients with LVAD
Classification by specialty
Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the relationship between bleeding complication and aquired von Willebrand syndrome after LVAD implantation, and to establish evidence for the creation of guidelines.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes VWF multimer analysis is performed on the blood sample before and after LVAD implantation.
Key secondary outcomes We acquire clinical data before and after LVAD implantation from the database of J-MACS registry.
Specific datas are as follows.
1) Medical history, diagnosis
2) Electrocardiogram
3) Blood sampling test
4) Echocardiography

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
0 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria Cases after LVAD implantation
Key exclusion criteria None.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshikatsu Saiki
Organization Tohoku University Graduate School of Medicine
Division name Division of Cardiovascular Surgery
Zip code
Address 1-1 Seiryocho, Aoba-ku, Sendai, 980-8574 Japan
TEL 022-717-7222
Email yoshisaiki@med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ko Sakatsume
Organization Tohoku University Graduate School of Medicine
Division name Division of Cardiovascular Surgery
Zip code
Address 1-1 Seiryocho, Aoba-ku, Sendai, 980-8574 Japan
TEL 022-717-7222
Homepage URL
Email kosakatsume@gmail.com

Sponsor
Institute Tohoku University Graduate School of Medicine,Division of Cardiovascular Surgery
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Non profit foundation
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
2017 Year 06 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 Preinitiation
Date of protocol fixation
2017 Year 03 Month 18 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None.

Management information
Registered date
2017 Year 06 Month 14 Day
Last modified on
2019 Year 06 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031812

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.