UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000036640
Receipt No. 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 (Ver. 1)

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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
Last 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
Email alongthelongestway2003@yahoo.co.jp

Public contact
1st 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
Email alongthelongestway2003@yahoo.co.jp

Sponsor
Institute Advanced Medical Emergency Department and Critical Care Center, Japan Red Cross Maebashi Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038700