|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
JPRN |
|
Last refreshed on:
|
17 October 2023 |
|
Main ID: |
JPRN-UMIN000017980 |
|
Date of registration:
|
20/06/2015 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Tranexamic acid for the treatment of significant traumatic brain injury: an international randomised, double blind placebo controlled trial
|
|
Scientific title:
|
Tranexamic acid for the treatment of significant traumatic brain injury: an international randomised, double blind placebo controlled trial - Clinical randomisation of an antifibrinolytic in significant head injury (CRASH 3) |
|
Date of first enrolment:
|
2015/06/22 |
|
Target sample size:
|
140 |
|
Recruitment status: |
Complete: follow-up complete |
|
URL:
|
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020829 |
|
Study type:
|
Interventional |
|
Study design:
|
Parallel Randomized
|
|
Phase:
|
Not selected
|
|
|
Countries of recruitment
|
|
Japan,Asia(except Japan),North America,South America,Europe,Africa
| | | | | | | |
|
Contacts
|
|
Name:
|
Ryuichiro
Egashira |
|
Address:
|
1-5-45 Yushima Bunkyo-ku Tokyo
113-8510
Japan |
|
Telephone:
|
03-3813-6111 |
|
Email:
|
rychr.0758@gmail.com |
|
Affiliation:
|
Medical Hospital,Tokyo Medical and Dental University Trauma and Acute Critical Care Medical Center |
|
|
Name:
|
Yasuhiro
Otomo |
|
Address:
|
1-5-45 Yushima Bunkyo-ku Tokyo
Japan |
|
Telephone:
|
03-3813-6111 |
|
Email:
|
otomo.accm@tmd.ac.jp |
|
Affiliation:
|
Medical Hospital,Tokyo Medical and Dental University Trauma and Acute Critical Care Medical Center |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
Exclusion criteria: 1)significant extra cranial bleeding (needing immediate blood transfusion) 2) antifibrinolytic agents in a patient
Age minimum:
20years-old
Age maximum:
Not applicable
Gender:
Male and Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Traumatic Brain Injury
|
|
Intervention(s)
|
Tranexamic acid As primary injection, 1g of Tranexamic acid is solved in 100ml NaCl0.9% and injected with 10 minutes. As maintenance dose, 1g of Tranexamic acid is infused in 500ml isotonic solution for 8 hrs.
Placebo(sodium chloride 0.9%) the procedure is the same as trial drug
|
|
Primary Outcome(s)
|
|
The primary outcome is death in hospital within 28 days of injury (cause-specific mortality will also be recorded)
|
|
Secondary ID(s)
|
|
NCT01402882
|
|
Source(s) of Monetary Support
|
|
JP Moulton Charitable Trust
|
|
Ethics review
|
Status: YES
Approval date: 20/04/2015
Contact:
mkan-rinsho.adm@tmd.ac.jp
Clinical Research Review Board TMDU Medical Hospital
03-5803-4575
mkan-rinsho.adm@tmd.ac.jp
|
|
Results
|
|
Results available:
|
Yes |
|
Date Posted:
|
|
|
Date Completed:
|
28/02/2019 |
|
URL:
|
|
|
|