UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058170 |
|---|---|
| Receipt number | R000066491 |
| Scientific Title | A study on quantitative assessment of hemostatic function in patients with thrombocytopenia due to liver cirrhosis |
| Date of disclosure of the study information | 2025/09/01 |
| Last modified on | 2025/06/13 15:12:25 |
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Basic information
Public title
A study on quantitative assessment of hemostatic function in patients with thrombocytopenia due to liver cirrhosis
Acronym
A study on quantitative assessment of hemostatic function in patients with thrombocytopenia due to liver cirrhosis
Scientific Title
A study on quantitative assessment of hemostatic function in patients with thrombocytopenia due to liver cirrhosis
Scientific Title:Acronym
A study on quantitative assessment of hemostatic function in patients with thrombocytopenia due to liver cirrhosis
Region
| Japan |
Condition
Condition
liver cirrhosis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study aimed to examine the correlation coefficient between bleeding time and hemostatic capacity measured by the HD assay in cirrhotic patients with platelet counts below 90,000/microL, as well as to investigate the correlation between hemostatic capacity obtained from the HD assay and various parameters such as blood coagulation factors, and to assess bleeding risk and bleeding complications following invasive procedures
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Examination of the correlation coefficient between bleeding time and hemostatic capacity measured by the HD assay in cirrhotic patients with platelet counts below 90,000/microL
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
Clinically diagnosed with liver cirrhosis
Has a platelet count of either 20,000-90,000/microL or 90,000-150,000/microL
18 years of age or older
Key exclusion criteria
Patients requested to be excluded from the main study
Patients with congenital platelet function disorders such as Glanzmann's thrombasthenia or Bernard-Soulier syndrome or von Willebrand disease
Patients currently taking antiplatelet or anticoagulant medications
Patients with severe anemia or hypoalbuminemia
Patients with embolic diseases such as myocardial infarction, cerebral infarction, or pulmonary embolism
Patients presenting with DIC due to severe infections, active bleeding, cancer, hematologic malignancies, or poor general condition
Any other patients deemed unsuitable for safe participation in this study by the attending physician
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Honda |
| Middle name | |
| Last name | Takashi |
Organization
Nagoya University Graduate School of Medicine
Division name
Gastroenterology
Zip code
4660065
Address
65 Tsurumai-cho, Showa-ku, Nagoya City, Aichi Prefecture
TEL
0527442169
norihiro@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Imai |
| Middle name | |
| Last name | Norihiro |
Organization
Nagoya University Graduate School of Medicine
Division name
Gastroenterology
Zip code
4660065
Address
65 Tsurumai-cho, Showa-ku, Nagoya City, Aichi Prefecture
TEL
0527442169
Homepage URL
norihiro@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
ZACROS Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University Graduate School of Medicine
Address
65 Tsurumai-cho, Showa-ku, Nagoya City, Aichi Prefecture
Tel
0527442169
ethics@med.nagoya-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
| 2025 | Year | 09 | 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
| 2025 | Year | 06 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The analysis will include all eligible cases among those who have provided informed consent and from whom the necessary samples and clinical information for evaluation have been obtained.
Bleeding time will be measured using the Ivy method (a procedure in which a small incision is made under upper arm pressure and the time to hemostasis is recorded). Blood coagulation factors and related parameters will be evaluated through blood tests.
In the T-TAS (Total Thrombus-formation Analysis System), patients with platelet counts below 90,000 will be assessed using the new HD assay, while those with platelet counts between 90,000 and 150,000 will be assessed using both the HD assay and the conventional AR assay.
Invasive procedures will include endoscopic treatments such as EVL (endoscopic variceal ligation) and EIS (endoscopic injection sclerotherapy), vascular interventions such as TACE (transcatheter arterial chemoembolization), as well as procedures such as RFA (radiofrequency ablation), MWA (microwave ablation), liver biopsy, and paracentesis for ascites.
Rebleeding after EVL or EIS will also be considered a bleeding event for evaluation purposes.
All data obtained from the above assessments will be compiled into a database using Excel and analyzed with statistical software.
For each patient, bleeding time and hemostatic capacity measured by T-TAS will be compared, and the presence or absence of bleeding complications will be added to the dataset to assess bleeding risk.
Management information
Registered date
| 2025 | Year | 06 | Month | 13 | Day |
Last modified on
| 2025 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066491
