UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057604 |
|---|---|
| Receipt number | R000065816 |
| Scientific Title | Investigation of Acquired von Willebrand Syndrome caused by Mechanical Circulatory Support Devices |
| Date of disclosure of the study information | 2025/05/01 |
| Last modified on | 2025/05/02 03:50:44 |
* 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
Investigation of Acquired von Willebrand Syndrome caused by Mechanical Circulatory Support Devices
Acronym
AvWS-MCS Study
Scientific Title
Investigation of Acquired von Willebrand Syndrome caused by Mechanical Circulatory Support Devices
Scientific Title:Acronym
Investigation of Acquired von Willebrand Syndrome caused by Mechanical Circulatory Support Devices
Region
| Japan |
Condition
Condition
Healthy adult volunteers
Classification by specialty
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assessment of the severity of acquired von Willebrand syndrome induced by ECMO and Impella, and evaluation of the therapeutic effects of von Willebrand factor concentrate
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
von Willebrand factor antigen level, ristocetin cofactor activity (RCo), large multimer index (LMI), and platelet aggregation function assessed by total thrombus-formation analysis system (t-TAS)
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Age 18 years or older
Body weight more than 45 kg for males and more than 40 kg for females
Able to provide written informed consent voluntarily
Key exclusion criteria
Individuals with chronic conditions requiring regular outpatient visits
Individuals taking prescribed medications on a regular basis
Individuals with a known hematologic disorder
Individuals who have ever been noted to have anemia, either during a hospital visit or health screening
Individuals who have participated in this study within the past four weeks
Individuals who are pregnant or may be pregnant
Individuals deemed unsuitable for participation as healthy volunteers by the principal investigator
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Mariko |
| Middle name | |
| Last name | Hayamizu |
Organization
Hokkaido University Hospital
Division name
Department of Emergency Medicine
Zip code
060-8648
Address
N14W5 Kita-ku, Sapporo 060-8648, Japan
TEL
011-706-7377
hayamizuma@gmail.com
Public contact
Name of contact person
| 1st name | Mariko |
| Middle name | |
| Last name | Hayamizu |
Organization
Hokkaido University Hospital
Division name
Department of Emergency Medicine
Zip code
060-8648
Address
N14W5 Kita-ku, Sapporo 060-8648, Japan
TEL
011-706-7377
Homepage URL
hayamizuma@gmail.com
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board for Life Science and Medical Research, Hokkaido University Hospital
Address
N14W5 Kita-ku, Sapporo 060-8648, Japan
Tel
011-706-7636
crjimu@huhp.hokudai.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
| 2025 | Year | 05 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 10 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To investigate the impact of mechanical circulatory support devices on von Willebrand factor (vWF), we will conduct in vitro experiments using blood obtained from healthy volunteers. The collected blood will be circulated through a mock extracorporeal membrane oxygenation (ECMO) circuit, and vWF degradation resulting from centrifugal pump operation will be evaluated. A parallel set of experiments will be performed using the Impella device to assess its specific effects on vWF. Upon elucidating the extent and nature of vWF alterations induced by ECMO and Impella, we will examine the potential for vWF concentrate supplementation to restore vWF levels. Furthermore, we will compare the efficacy of different administration strategies, including single bolus and continuous infusion, in mitigating device-induced vWF depletion.
Management information
Registered date
| 2025 | Year | 04 | Month | 14 | Day |
Last modified on
| 2025 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065816
