UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056122 |
|---|---|
| Receipt number | R000064110 |
| Scientific Title | The effect of tranexamic acid on perioperative bleeding in patients undergoing spine surgery |
| Date of disclosure of the study information | 2024/11/20 |
| Last modified on | 2025/05/13 21:09:37 |
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Basic information
Public title
The effect of tranexamic acid on perioperative bleeding in patients undergoing spine surgery
Acronym
The effect of tranexamic acid on perioperative bleeding in patients undergoing spine surgery
Scientific Title
The effect of tranexamic acid on perioperative bleeding in patients undergoing spine surgery
Scientific Title:Acronym
The effect of tranexamic acid on perioperative bleeding in patients undergoing spine surgery
Region
| Japan |
Condition
Condition
spine disease
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Tranexamic acid (TXA) has been used to reduce perioperative bleeding in various surgery because of its antifibrinolytic effect. Recently, the patients undergoing spine surgery in our hospital received a loading dose of TXA (1000 mg) before surgery followed by 100 mg/hour until the end of surgery. The purpose of this retrospective study is to evaluate the efficacy of TXA administration on the perioperative blood loss in patients undergoing spine surgery. Secondary outcome is the correlation between the estimated plasma cincentration of TXA and perioperative blood loss.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
perioperative blood loss
Key secondary outcomes
the correlation between estimated plasma concentration of TXA and perioperative blood loss, the changes of hemoglobin concentrations, intraoperative blood loss, intraoperative infusion volume, intraoperative blood transfusion volume, postoperative 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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients who underwent spine surgery
Key exclusion criteria
Patients who could not give consent for this clinical research
Target sample size
212
Research contact person
Name of lead principal investigator
| 1st name | Toru |
| Middle name | |
| Last name | Goyagi |
Organization
Akita University Graduate School of Medicine, Akita, Japan
Division name
Department of Anesthesiology and Intensive Care Medicine
Zip code
010-8543
Address
1-1-1, Hondo, Akita
TEL
0188341111
ts115h.4mmz@gmail.com
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Saga |
Organization
Akita University Graduate School of Medicine, Akita, Japan
Division name
Department of Anesthesiology and Intensive Care Medicine
Zip code
010-8543
Address
1-1-1, Hondo, Akita
TEL
0188341111
Homepage URL
ts115h.4mmz@gmail.com
Sponsor or person
Institute
Akita University
Institute
Department
Personal name
Funding Source
Organization
nil
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Akita University Graduate School of Medicine, Akita, Japan
Address
1-1-1, Hondo, Akita
Tel
0188341111
ts115h.4mmz@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 | 20 | Day |
Related information
URL releasing protocol
http://www2.hos.akita-u.ac.jp/chiken/info/pdf/20171120_1862.pdf
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
212
Results
A total of 212 patients underwent surgery. Propensity score matching yielded 62 patients each in the TXA and no TXA groups. Perioperative blood loss did not differ significantly, but delta Hb was significantly lower in the TXA group. Maximum TXA concentration showed no correlation with perioperative blood loss or transfusion volume. TXA concentration at the end of surgery was negatively correlated with perioperative blood loss and transfusion volume.
Results date posted
| 2025 | Year | 05 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients who underwent spine surgery at our institution were selected, including procedures such as anterior cervical fusion, posterior instrumented fusion, posterior lumbar interbody fusion, laminectomy, foraminotomy, spondylectomy.
Participant flow
control group; patients who underwent surgery with no tnanexamic acid (from 1 January 2015 to 31 December 2015)
tranexamic acid group; patients who underwent surgery with TXA administration ( from 1 July 2016 to 30 June 2017)
Adverse events
nil
Outcome measures
the correlation between estimated plasma concentration of TXA and perioperative blood loss, the changes of hemoglobin concentrations, intraoperative blood loss, intraoperative infusion volume, intraoperative blood transfusion volume, postoperative blood transfusion volume
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 18 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 18 | Day |
Date of closure to data entry
| 2024 | Year | 12 | Month | 18 | Day |
Date trial data considered complete
| 2024 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 12 | Month | 31 | Day |
Other
Other related information
A retrospective review was conducted for the records in patients who underwent surgery without TXA administration (control group, from 1 January 2015 to 31 December 2015) and patients who underwent surgery with TXA administration (TXA group, from 1 July 2016 to 30 June 2017).
Management information
Registered date
| 2024 | Year | 11 | Month | 11 | Day |
Last modified on
| 2025 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064110
