UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042973 |
|---|---|
| Receipt number | 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 21:29:18 |
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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
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
s2doi@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049059
