UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016443 |
|---|---|
| Receipt number | R000017521 |
| Scientific Title | Effects of tranexamic acid to perioperative bleeding amount in posterior lumbar fusion |
| Date of disclosure of the study information | 2015/02/04 |
| Last modified on | 2016/02/06 10:42:22 |
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Basic information
Public title
Effects of tranexamic acid to perioperative bleeding amount in posterior lumbar fusion
Acronym
Effects of tranexamic acid to perioperative bleeding amount in posterior lumbar fusion
Scientific Title
Effects of tranexamic acid to perioperative bleeding amount in posterior lumbar fusion
Scientific Title:Acronym
Effects of tranexamic acid to perioperative bleeding amount in posterior lumbar fusion
Region
| Japan |
Condition
Condition
Perioperative adult patients undergoing posterior lumbar fusion
Classification by specialty
| Orthopedics | Anesthesiology | Operative medicine |
| Blood transfusion | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the influence of tranexamic acid to perioperative bleeding amount in adult patients undergoing posterior lumbar fusion
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bleeding amount in operation and postoperative 24 hours
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Using taranexamic acd
Interventions/Control_2
Not using tranexamic acid
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
Perioperative adult patients undergoing posterior lumbar fusion
Key exclusion criteria
Patients with thromboembolism, patients using aniticoagulants, patients with CKD(eGFRcreat<45)
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takerou Terashi |
Organization
Kagoshima red cross hospital
Division name
Department of anesthesiology
Zip code
Address
2545Hrakawa-cho, Kagoshima City, Kagoshima 891-0133, Japan
TEL
099-261-2111
terashi@m2.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takerou Terashi |
Organization
Kagoshima red cross hospital
Division name
Department of anesthesiology
Zip code
Address
2545Hrakawa-cho, Kagoshima City, Kagoshima 891-0133, Japan
TEL
099-261-2111
Homepage URL
terashi@m2.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima red cross hospital
Institute
Department
Personal name
Funding Source
Organization
Kagoshima red cross hospital
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
Address
Tel
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
鹿児島赤十字病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | Month | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 30 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 02 | Month | 04 | Day |
Last modified on
| 2016 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017521
