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 UMIN000042973
Receipt No. R000049059
Scientific Title Prospective observational study of the association between acquired von Willebrand syndrome and bleeding due to the use of pump catheters for assisted circulation
Date of disclosure of the study information 2021/01/13
Last modified on 2021/01/13

* 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 Prospective observational study of the association between acquired von Willebrand syndrome and bleeding due to the use of pump catheters for assisted circulation
Acronym Prospective observational study of the association between acquired von Willebrand syndrome and bleeding due to the use of pump catheters for assisted circulation
Scientific Title Prospective observational study of the association between acquired von Willebrand syndrome and bleeding due to the use of pump catheters for assisted circulation
Scientific Title:Acronym Prospective observational study of the association between acquired von Willebrand syndrome and bleeding due to the use of pump catheters for assisted circulation
Region
Japan

Condition
Condition acquired von Willebrand syndrome
Classification by specialty
Cardiology Hematology and clinical oncology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 major bleeding
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes major bleeding
Key secondary outcomes all cause death

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 Patients who have received a supplemental circulatory pump catheter for cardiogenic shock, and who have received sufficient explanation and written consent from the patient or his/her legal representative to participate in this study.
Key exclusion criteria Patients who have difficulty in collecting blood more than once a day
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Shunichi
Middle name
Last name Doi
Organization St. Marianna University School of Medicine
Division name Division of Cardiology, Department of Internal Medicine
Zip code 216-8511
Address 2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa
TEL 044-977-8111
Email s2doi@marianna-u.ac.jp

Public contact
Name of contact person
1st name Shunichi
Middle name
Last name Doi
Organization St. Marianna University School of Medicine
Division name Division of Cardiology, Department of Internal Medicine
Zip code 216-8511
Address 2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa
TEL 044-977-8111
Homepage URL
Email s2doi@marianna-u.ac.jp

Sponsor
Institute St. Marianna University School of Medicine
Institute
Department

Funding Source
Organization St. Marianna University School of Medicine
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 St. Marianna University School of Medicine
Address 2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa
Tel 044-977-8111
Email k-sienbu.mail@marianna-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 01 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
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
2021 Year 01 Month 12 Day
Date of IRB
Anticipated trial start date
2021 Year 01 Month 12 Day
Last follow-up date
2025 Year 01 Month 12 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information under observation

Management information
Registered date
2021 Year 01 Month 12 Day
Last modified on
2021 Year 01 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049059

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.