UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025236 |
|---|---|
| Receipt number | R000029025 |
| Scientific Title | Comparison of Crystalloids and Colloids in Acute Resuscitation of Trauma Patients |
| Date of disclosure of the study information | 2018/12/01 |
| Last modified on | 2016/12/12 16:30:17 |
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Basic information
Public title
Comparison of Crystalloids and Colloids in Acute Resuscitation of Trauma Patients
Acronym
Comparison of Crystalloids and Colloids in Acute Resuscitation of Trauma Patients
Scientific Title
Comparison of Crystalloids and Colloids in Acute Resuscitation of Trauma Patients
Scientific Title:Acronym
Comparison of Crystalloids and Colloids in Acute Resuscitation of Trauma Patients
Region
| Asia(except Japan) |
Condition
Condition
Hemorrhagic shock secondary to trauma
Classification by specialty
| Surgery in general | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether crystalloids, colloids, or a combination of the two, is the best option for fluid resuscitation in trauma patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mortality in the Emergency Department.
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
| 12 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All patients presenting to the Emergency Department with signs of hemorrhagic shock.
Key exclusion criteria
Patients with pre-existing liver, kidney, or heart disease.
Target sample size
516
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Omar Abbas Ahmed Malik |
Organization
Dow University of Health Sciences
Division name
Dow Medical College
Zip code
Address
31/1, Zulfiqar Street 1, Phase 8, DHA, Karachi, Pakistan
TEL
00923362363569
omar.a.a.malik@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Khawar Iqbal |
Organization
Jinnah Postgraduate Medical Centre
Division name
Surgical Ward 2
Zip code
Address
Rafiqui Shaheed Road, Karachi-75510
TEL
00923337958208
Homepage URL
dr_khawariqbal@yahoo.com
Sponsor or person
Institute
Jinnah Postgraduate Medical Centre
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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
| 2018 | Year | 12 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 11 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 12 | Month | 25 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study will compare outcomes of three groups of patients: those being resuscitated with only crystalloids, only colloids, and with both crystalloids and colloids. The choice of treatment will be left to the doctors on duty.
Management information
Registered date
| 2016 | Year | 12 | Month | 12 | Day |
Last modified on
| 2016 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029025
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
