UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036640 |
|---|---|
| Receipt number | R000038700 |
| Scientific Title | Development study of the Pre-Hospital Traumatic Bleeding Severity Score for the On-Scene Prediction of the Need for Massive Transfusion |
| Date of disclosure of the study information | 2019/09/30 |
| Last modified on | 2019/05/02 18:44:59 |
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Basic information
Public title
Development study of the Pre-Hospital Traumatic Bleeding Severity Score for the On-Scene Prediction of the Need for Massive Transfusion
Acronym
Development study of the ph-TBSS for the On-Scene Prediction of the Need for MT
Scientific Title
Development study of the Pre-Hospital Traumatic Bleeding Severity Score for the On-Scene Prediction of the Need for Massive Transfusion
Scientific Title:Acronym
Development study of the ph-TBSS for the On-Scene Prediction of the Need for MT
Region
| Japan |
Condition
Condition
Trauma
Classification by specialty
| Emergency medicine | Blood transfusion | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
develop and evaluate the ph-TBSS allowing determination in the pre-hospital setting and analyze the accuracy to predict the need for MT
Basic objectives2
Others
Basic objectives -Others
Diagnostic Study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the Need for the Massive Transfusion
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
High Energy Trauma treated by Helicopter Emergency Medical Service
Key exclusion criteria
Patients suffering a cardiac arrest at the scene
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Ogura |
Organization
Advanced Medical Emergency Department and Critical Care Center, Japan Red Cross Maebashi Hospital
Division name
Department of Emergency Medicine and Critical Care Medicine
Zip code
371-0811
Address
Advanced Medical Emergency Department and Critical Care Center, Japan Red Cross Maebashi Hospital
TEL
0272653333
alongthelongestway2003@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Takayuki |
| Middle name | |
| Last name | Ogura |
Organization
Advanced Medical Emergency Department and Critical Care Center, Japan Red Cross Maebashi Hospital
Division name
Department of Emergency Medicine and Critical Care Medicine
Zip code
371-0811
Address
Advanced Medical Emergency Department and Critical Care Center, Japan Red Cross Maebashi Hospital
TEL
0272653333
Homepage URL
alongthelongestway2003@yahoo.co.jp
Sponsor or person
Institute
Advanced Medical Emergency Department and Critical Care Center, Japan Red Cross Maebashi Hospital
Institute
Department
Personal name
Funding Source
Organization
Advanced Medical Emergency Department and Critical Care Center, Japan Red Cross Maebashi Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Red Cross Maebashi Hospital
Address
Asakura-Machi 389-1
Tel
0272653333
alongthelongestway2003@yahoo.co.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | Month | 30 | Day |
Related information
URL releasing protocol
non
Publication of results
Unpublished
Result
URL related to results and publications
non
Number of participants that the trial has enrolled
1039
Results
The median age was 58.0 years, 78.9% were male, blunt trauma was the mechanism of injury in 98.1%, the median Revised Trauma Score was 7.84, and 6.6% underwent MT. The AUC of the ph-TBSS for the MT was 0.97 (Youden Index=17, sensitivity 92.6%, specificity 97.1%). The AUC of the ph-TBSS for MT in ROC comparison analysis was significantly higher than other scores used to predict the need for MT (AUC: ph-TBSS=0.97, Lactate=0.91, Shock Index=0.89, ABC Score=0.83) (P<0.0175).
Results date posted
| 2019 | Year | 05 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
1039 patients who suffered high-energy traumatic injuries and treated by Gunma HEMS.
Participant flow
The medical records of 1039 patients who suffered high-energy traumatic injuries were reviewed and 1025 patients were enrolled in the study after exclusion of 14 patients with incomplete data
Adverse events
No
Outcome measures
Massive Transfusion
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2012 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective Diagnostic Study
Management information
Registered date
| 2019 | Year | 05 | Month | 02 | Day |
Last modified on
| 2019 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038700
