UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028321 |
|---|---|
| Receipt number | R000032399 |
| Scientific Title | Evaluation of residual effect of perioperative anticoagulat and antiplatelet drugs by using Sonoclot. |
| Date of disclosure of the study information | 2017/07/21 |
| Last modified on | 2021/08/11 13:29:54 |
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Basic information
Public title
Evaluation of residual effect of perioperative anticoagulat and antiplatelet drugs by using Sonoclot.
Acronym
Evaluation of residual effect of perioperative anticoagulat and antiplatelet drugs by using Sonoclot.
Scientific Title
Evaluation of residual effect of perioperative anticoagulat and antiplatelet drugs by using Sonoclot.
Scientific Title:Acronym
Evaluation of residual effect of perioperative anticoagulat and antiplatelet drugs by using Sonoclot.
Region
| Japan |
Condition
Condition
Patients who are given anticoagulants or antiplatelet drugs in elective operations.
Classification by specialty
| Anesthesiology | Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of Sonoclot when the residual inhibitory action of coagulation or platelet in case the anticoagulants or antiplatelet drugs are continued in elective operations.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The results of Sonoclot including activated clotting time (ACT), clot rate, platelet function.
Key secondary outcomes
Types of anticoagulant / antiplatelet drugs, drug holiday, presence or absence of heparin substitution, disease name, operation type, bleeding volume, blood transfusion volume.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Among patients undergoing anesthesia management by elective operation, patients who are continuing anticoagulant / antiplatelet drugs, patients who were discontinued, patients who have not been administered.
Key exclusion criteria
Patients who can not obtain consent, emergency operation patients, patients with anemia, patients who have received transfusion within 2 weeks, patients with diagnosed blood / coagulation abnormality, patients with renal dysfunction, dialysis patients, hepatic dysfunction, patients who have stopped anticoagulant / antiplatelet drugs but who do not satisfy the drug holiday period specified in this study.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Motonobu |
| Middle name | |
| Last name | Kimizuka |
Organization
Sapporo Medical University, School of Medicine
Division name
Department of Anesthesiology
Zip code
0608543
Address
S.1, W.16, Chuo-ku, Sapporo, Japan
TEL
0116889663
m.kimizuka@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Motonobu |
| Middle name | |
| Last name | Kimizuka |
Organization
Sapporo Medical University, School of Medicine
Division name
Department of Anesthesiology
Zip code
0608543
Address
S.1, W.16, Chuo-ku, Sapporo, Japan
TEL
0116889663
Homepage URL
m.kimizuka@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University, School of Medicine, Department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Sapporo Medical University, School of Medicine, Department of Anesthesiology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kitami Red Cross Hospital, Hokkaido Prefectural Kitami Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo Medical University Institutional Review Board
Address
S.1, W.16, Chuo-ku, Sapporo, Japan
Tel
0116112111
rskk@sapmed.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
札幌医科大学付属病院（北海道）、北見赤十字病院（北海道）、道立北見病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 07 | Month | 21 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 07 | Month | 21 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 08 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 28 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
After the protocol was determined, it took four years until the ethics committee to review. This is because we spent time to coordinate between hospitals due to personnel changes.
Management information
Registered date
| 2017 | Year | 07 | Month | 21 | Day |
Last modified on
| 2021 | Year | 08 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032399
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
