UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001059 |
|---|---|
| Receipt number | R000001285 |
| Scientific Title | A prospective, multicentre, observational trial for hemodynamic reaction following initial fluid resuscitation in patients with hemorrhagic shock due to blunt trauma |
| Date of disclosure of the study information | 2008/03/07 |
| Last modified on | 2008/08/08 17:17:29 |
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Basic information
Public title
A prospective, multicentre, observational trial for hemodynamic reaction following initial fluid resuscitation in patients with hemorrhagic shock due to blunt trauma
Acronym
Hemodynamic reaction following initial fluid resuscitation in patients with hemorrhagic shock
Scientific Title
A prospective, multicentre, observational trial for hemodynamic reaction following initial fluid resuscitation in patients with hemorrhagic shock due to blunt trauma
Scientific Title:Acronym
Hemodynamic reaction following initial fluid resuscitation in patients with hemorrhagic shock
Region
| Japan |
Condition
Condition
Trauma patients with hemorrhagic shock
Classification by specialty
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Japan Advanced Trauma Evaluation and Care (JATEC) and Advanced Trauma Life Support (ATLS) suggest that, in patients with hemorrhagic shock, the response and the treatment policy for initial fluid resuscitation should be categorized into three groups: 1) responder; 2) transient responder; and 3) non-responder. Hemorrhagic shock is comprehensively diagnosed based on several clinical findings, such as skin color, pulse rate, blood pressure, consciousness levels, etc. However, the diagnosis varies depending on clinical experiences of each physician and/or each ER system. For clinically investigating hemorrhagic shock, an evidence-based objective index for the shock is necessary. Research results and scientific literature that have been reported in the past used systolic blood pressure (SBP) and HR as standard criteria for evaluation of the shock. However, the rationale for setting BP and HR for criteria of the categorization of hemorrhagic shock, still remain uncertain.
This study aims to 1) define (levels of) hemorrhagic shock using BP, HR, and transfused volume, and 2) determine treatment policy based on response to initial fluid resuscitation using the results of 1), and 3) determine whether the coagulation function and lactic acid value at admission can be used to categorize the shock into responder, transient responder, or non-responder.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Character of patients with hemorrhagic shock
2) Systolic blood pressure (SBP) and heart rate (HR) on admission
3) SBP and HR at the time when 1L of fluid replacement was administered.
4) SBP and HR at the time when 2L was administered.
5) SBP and HR at the time when the management of ER was finished.
6) Total volume of fluid replacement and blood transfusion at ER
7) Total volume of fluid replacement and blood transfusion during 24 hr
8) Details of interventional treatment performed for hemorrhage
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients who received initial fluid resuscitation for hemorrhagic shock
(2) Patients with physiological abnormality (Step 1), anatomical abnormality (Step 2), or mechanism of injury (high-energy injuries: Step 3) defined by JATEC (guideline p233).
Patients who meet criteria for 1 or 2 above.
Key exclusion criteria
(1) Penetrating trauma
(2) When the physician selected permissive hypotension therapy
(3) Cardiopulmonary arrest
(4) Patients whose fluid therapy started before admission
(5) Patients with terminal stage of chronic disease
(6) When the physician consider that the initial fluid resuscitation therapy is inappropriate for the patient (state the specific reason)
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akio Kimura |
Organization
International Medical Center of Japan, Tokyo, Japan
Division name
Department of Emergency Medicine and Traumatology and Toxicology
Zip code
Address
1-21-1 Toyama, Shinjyuku-ku, Tokyo, 162-8655 Japan
TEL
03-3202-7181
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akiyoshi Hagiwara |
Organization
National Defense Medical College, Japan
Division name
Department of Traumatology and Critical Care Medicine
Zip code
Address
3-2 Namiki, Tokorozawa, Saitama, 359-8513 Japan
TEL
04-2995-1511
Homepage URL
boeihagi@ndmc.ac.jp
Sponsor or person
Institute
The General Planning Committee of Japanese Association for the Surgery of Trauma
Institute
Department
Personal name
Funding Source
Organization
The Japanese Association for the Surgery of Trauma
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
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
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 03 | Month | 07 | 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
Completed
Date of protocol fixation
| 2007 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 12 | Month | 01 | Day |
Other
Other related information
A prospective, multicentre, observational trial
Management information
Registered date
| 2008 | Year | 02 | Month | 29 | Day |
Last modified on
| 2008 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001285
