Protocol summary
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Study aim
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The main purpose of this study is determination of alterations in serum level of inflammatory markers of interferon Gamma and interleukins 1, 5, and 6, and TNF-Alpha that would be measured at baseline and after one hour from surgery among patients with femoral fracture under early versus late surgery.
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Design
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Randomised, superiority, parallel group trial with blinded outcome assessment
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Settings and conduct
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Rasool Hospital , Sattarkhan Street
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Fracture of femoral shaft and aging from 20 to 50 years
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Intervention groups
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Patients with femoral fracture in the 2 groups were under the same surgery, before 24 hours of the visit to the hospital and after 24 hours of a visit to the hospital
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Main outcome variables
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TNF-Alph , Interleukin 6 , interlukin 5 , interlukin 1 , INF gama
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2014110519818N1
Registration date:
2015-01-03, 1393/10/13
Registration timing:
registered_while_recruiting
Last update:
2018-12-09, 1397/09/18
Update count:
1
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Registration date
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2015-01-03, 1393/10/13
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Iran University of Medical Sciences
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Expected recruitment start date
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2014-12-22, 1393/10/01
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Expected recruitment end date
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2015-09-23, 1394/07/01
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Actual recruitment start date
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2015-01-01, 1393/10/11
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Actual recruitment end date
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2015-09-19, 1394/06/28
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Trial completion date
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2015-10-23, 1394/08/01
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Scientific title
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Alterations in serum inflammatory markers in patients under early and late surgery for femoral fractures
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Public title
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Inflammation in femoral fractures
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Fracture of femoral shaft
no any other concomitant injury
aging from 20 to 50 years
Exclusion criteria:
Presence of concomitant injuries
presence of chronic inflammatory diseases
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Age
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From 20 years old to 50 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
38
Actual sample size reached:
38
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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simple randomization
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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double blind , That is not the patient knew which group under the surgery and not see any sick doctor knew when and what time the surgery group
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2010-09-23, 1389/07/01
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Ethics committee reference number
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93/912
Health conditions studied
1
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Description of health condition studied
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Fracture of shaft of femur
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ICD-10 code
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S72.3
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ICD-10 code description
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Fracture of shaft of femur
Primary outcomes
1
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Description
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Interferon Gamma
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Timepoint
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one hour after surgery
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Method of measurement
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Lab Kit
2
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Description
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Interleukin 1
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Timepoint
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one hour after surgery
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Method of measurement
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Lab Kit
3
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Description
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Interleukin 5
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Timepoint
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one hour after surgery
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Method of measurement
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Lab Kit
4
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Description
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Interleukin 6
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Timepoint
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one hour after surgery
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Method of measurement
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Lab Kit
5
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Description
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TNF-Alph
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Timepoint
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one hour after surgery
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Method of measurement
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Lab Kit
Secondary outcomes
1
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Description
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Interlukin 1
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Timepoint
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One hour after surgery
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Method of measurement
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Lab Kit
2
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Description
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IFN-Gamma
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Timepoint
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One hour after surgery
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Method of measurement
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lab kit
3
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Description
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TNF-Alpha
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Timepoint
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one hour after surgery
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Method of measurement
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lab kit
4
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Description
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interlukin 5
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Timepoint
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one hour after surgery
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Method of measurement
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lab kit
5
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Description
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interlukin 6
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Timepoint
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one hour after surgery
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Method of measurement
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lab kit
Intervention groups
1
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Description
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all patients with fractures of the femur bone that before 24 hours of admission to the emergency room, a common method of surgery are located and The fracture is fixed only by the plate
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Category
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Treatment - Surgery
2
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Description
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all patients with fractures of the femur bone that After 24 hours of admission to the emergency room, a common method of surgery are located and The fracture is fixed only by the plate
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Category
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Treatment - Surgery
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Iran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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Just part of the original data, such as information related to the outcome or the possibility of sharing it
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When the data will become available and for how long
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Access the course start 6 months after printing the results
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To whom data/document is available
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Just for researchers working in academic and scientific institutions will be available
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Under which criteria data/document could be used
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Only the fields of data use is possible
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From where data/document is obtainable
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Dr. Babak otoukesh to the following phone and email address be referred
babak.otoukesh@gmail.com
+989126843678
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What processes are involved for a request to access data/document
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After reviewing the request will be answered within a maximum of 1 month
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Comments
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The result of this research paper has been published and accessible to the public via the link below :
https://www.termedia.pl/Evaluation-of-inflammatory-response-in-patients-undergoing-surgical-treatment-for-early-and-delayed-femoral-fractures,19,28559,1,1.html