Now a day traumas are one of the most challenging fields in medicine.About 90% of severe traumas are accompanied by bone fractures.The main reason of mortality in blunt severe traumas is multiple organ failure, which is caused by the inflammatory response following trauma. Main acts of this inflammatory response are modified by Tumor necrosis factor α, Interleukin 1β and Interleukin 6. Plasmapheresis a method in which inflammatory mediators and auto-antibodies are extracted from blood. In this study it will be tried to assess effect of plasmapheresis on respiratory status and acidosis as a part of recovery process.
In this clinical trial 12 patients with complex instable hip or long bone fracture who will attend Emergency department of Emam Reza medical-educational center (Tabriz, Iran) and will be admitted to intense care unit, will be included in study. Included patients will undergo Plasmapheresis and its effect on respiratory status and acidosis will be examined.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014082718946N1
Registration date:2014-10-03, 1393/07/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-10-03, 1393/07/11
Registrant information
Name
Reza Piri
Name of organization / entity
Emam Reza educational-medical center, Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 5372
Email address
reza.piri@rocketmail.com
Recruitment status
Recruitment complete
Funding source
Tabriz University of medical sciences
Expected recruitment start date
2014-10-01, 1393/07/09
Expected recruitment end date
2015-10-01, 1394/07/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of plasmapheresis on respiratory condition and acidosis of patients with unstable complex pelvic fracture and long bones
Public title
Effects of plasmapheresis on patients with unstable complex pelvic fracture and long bones
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 15 and 65 years old; having unstable complex hip or long bone fracture; being admitted to Intense care unit; being tachypneic; suffering respiratory distress; having low oxygen saturation; having Acidosis.
Exclusion criteria: having renal failure history; Glascow coma score less than 8 at time of hospitalization; having angioplasty history; having history of chronic respiratory disease (e.g. Asthma, chronic obstructive pulmonary disease,...); concomitant renal, hepatic, cardiac or central nervous system injury in recent trauma; unstable hemodynamic; requiring surgical intervention.
Age
From 15 years old to 65 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
12
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Central campus of Tabriz University of Medical Sciences, Golgasht street, Azadi avenue.
City
Tabriz
Postal code
Approval date
2014-09-01, 1393/06/10
Ethics committee reference number
9397
Health conditions studied
1
Description of health condition studied
Unstable complex fracture of pelvic or long bones.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Respiratory rate
Timepoint
Daily and 2 hours after intervention.
Method of measurement
Counting by physician
2
Description
Respiratory distress
Timepoint
Daily and 2 hours after intervention.
Method of measurement
Examination by physician.
Secondary outcomes
1
Description
Arterial blood gas.
Timepoint
Daily and 2 hours after intervention.
Method of measurement
Arterial blood gases laboratory.
Intervention groups
1
Description
Intervention group: Patients with unstable complex fracture of hip and long bones, who are admitted to intense care unit, will be examined to assess their respiratory status (Arterial blood gas, respiratory rate and respiratory distress) every day 6 am. Patients will undergo plasmapheresis after acquiring mentioned parameters. Two hours after plasmapheresis , patients will undergo mentioned examinations again. Patients will undergo plasmapheresis every 24 hours until their condition has not changed or their hemodynamic status has not deteriorated.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza medical-educational centre, Tarbiz University of Medical Sciences
Full name of responsible person
Street address
City
Tarbiz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Rashidi
Street address
Central campus of Tabriz University of Medical Sciences, Golgasht street, Azadi avenue.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Emam Reza educational-medical center
Full name of responsible person
Dr. Ramin Azhough
Position
Assistant professor of general surgery
Other areas of specialty/work
Street address
Emam Reza educational-medical centre, Azadi street, Golgasht Avenue
City
Tabriz
Postal code
Phone
+98 41 3334 1317
Fax
Email
ali.shahavand92@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Emam Reza educational-medical center
Full name of responsible person
Dr. Ramin Azhough
Position
Assistant professor of general surgery
Other areas of specialty/work
Street address
Emam Reza educational-medical centre, Azadi street, Golgasht Avenue
City
Tabriz
Postal code
Phone
+98 41 3334 1317
Fax
Email
ali.shahavand92@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Emam Reza educational-medical center
Full name of responsible person
Ali Shahavand
Position
MD, general surgery resident
Other areas of specialty/work
Street address
City
Tabriz
Postal code
Phone
Fax
Email
ali.shahavand92@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)