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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000025236
Receipt No. R000029025
Official scientific title of the study 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

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Basic information
Official scientific title of the study Comparison of Crystalloids and Colloids in Acute Resuscitation of Trauma Patients
Title of the study (Brief title) 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 Omar Abbas Ahmed Malik
Organization Dow University of Health Sciences
Division name Dow Medical College
Address 31/1, Zulfiqar Street 1, Phase 8, DHA, Karachi, Pakistan
TEL 00923362363569
Email omar.a.a.malik@gmail.com

Public contact
Name of contact person Khawar Iqbal
Organization Jinnah Postgraduate Medical Centre
Division name Surgical Ward 2
Address Rafiqui Shaheed Road, Karachi-75510
TEL 00923337958208
Homepage URL
Email dr_khawariqbal@yahoo.com

Sponsor
Institute Jinnah Postgraduate Medical Centre
Institute
Department

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)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2016 Year 11 Month 21 Day
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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029025

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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