UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055988 |
|---|---|
| Receipt number | R000063760 |
| Scientific Title | Investigation of the variability of three types of activated clotting time point-of-care systems in cardiac surgery |
| Date of disclosure of the study information | 2024/11/16 |
| Last modified on | 2024/10/30 10:41:33 |
* 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 the variability of three types of activated clotting time point-of-care systems in cardiac surgery
Acronym
Investigation of the variability of activated clotting time point-of-care systems
Scientific Title
Investigation of the variability of three types of activated clotting time point-of-care systems in cardiac surgery
Scientific Title:Acronym
Investigation of the variability of activated clotting time point-of-care systems
Region
| Japan |
Condition
Condition
cardiac surgery
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the differences in ACT at each phase of the three types of ACT measurement devices (Actalyke MINI 2, Hemochron Signature Elite, i-STAT).
To examine the types and degree of confounding factors that affect ACT in each of the three types of measurement devices.
To examine whether the ACT target value should be changed depending on the measurement device and the values of various confounding factors.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Activated clotting time: before heparin injection, 3 minutes after heparin injection, 30 minutes after the start of cardiopulmonary bypass, after protamine injection, before returning to the room
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients underwent elective cardiovascular surgery under cardio-pulmonary bypass (ACT more than 480 sec) will be assessed.
Key exclusion criteria
1. Patients with significantly decreased coagulation factors, platelets, and albumin, due to sepsis, etc., preoperatively.
2. Emergency surgery.
3. Patients who have refused to participate in this study.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | YUKI |
| Middle name | |
| Last name | NUMATA |
Organization
Dokkyo Medical University
Division name
Department of Anesthesiology
Zip code
321-0293
Address
880, Kitakobayashi, Mibu, Tochigi, Japan
TEL
0282-86-1111
numagene@gmail.com
Public contact
Name of contact person
| 1st name | YUKI |
| Middle name | |
| Last name | NUMATA |
Organization
Dokkyo Medical University
Division name
Department of Anesthesiology
Zip code
321-0293
Address
880, Kitakobayashi, Mibu, Tochigi, Japan
TEL
0282-86-1111
Homepage URL
numagene@gmail.com
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Dokkyo Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Dokkyo Medical University
Address
Dokkyo Medical University
Tel
0282-86-1111
numagene@gmail.com
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
| 2024 | Year | 11 | Month | 16 | 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 | 11 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Investigation of the variability of activated coagulation time point-of-care systems using three different measuring instruments in cardiac surgery.
Management information
Registered date
| 2024 | Year | 10 | Month | 30 | Day |
Last modified on
| 2024 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063760
