Objectives: We aimed to use preoperative intravenous iron therapy in patients undergoing elective rhinoplastic surgery to improve preoperative hemoglobin concentrations, reduce the need for RBC transfusion, and decrease complications compared with placebo.Design: A randomized, double-blinded clinical trial is designed to evaluate the effects of preoperative intravenous iron in candidates for rhinoplastic surgery in Shiraz Rajaei Hospital. Sixty adult between the ages of 18-40 will be randomized to receive either intravenous iron or the placebo before rhinoplastic surgery.Setting and conduct: A questionnaire that included demographic information, medical history, hemodynamic values before, during and after the operation, duration of surgery, and the amount of intraoperative bleeding will be recorded. Bleeding collected with surgical gauzes and the amount of blood in the suction device will be calculated as the total amount of intraoperative bleeding. Inclusion criteria: Adult patients; no history of drug use; willingness to cooperate in the study. Exclusion criteria: known allergy to the study drug; history of thromboembolic episodes; iron overload; hematologic diseases; hepatic and renal dysfunction; preoperative autologous blood donation and lack of signed informed consent. Intervention: The intervention group will receive an intravenous VENOFER- iron sucrose injection, 500 mg dissolved in normal saline 0.9 % via pump infusion for 30 min. Patients in the control group will receive " placebo" as same bolus volume in a 30-minute intravenous infusion. Main outcome measures: Hemodynamic values, intraoperative estimated blood loss (EBL) and surgical duration.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201701221674N14
Registration date:2017-06-02, 1396/03/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-06-02, 1396/03/12
Registrant information
Name
Hamid Reza Eftekharian
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3636 4001
Email address
eftekharhr@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Expected recruitment start date
2017-05-15, 1396/02/25
Expected recruitment end date
2018-01-20, 1396/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Role of preoperative intravenous iron in perioperative blood management after rhinoplastic surgery: A Clinical Trial
Public title
Efficacy of preoperative intravenous iron in perioperative blood management after rhinoplastic surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Male or female patients more than 18 years of age; no history of drug use; and willingness to cooperate in this study are enrolled. Exclusion criteria: patients with known allergy to the study drug; history of thromboembolic episodes; iron overload; hematologic diseases; hepatic and renal dysfunction; preoperative autologous blood donation and lack of signed informed consent will be excluded.
Age
From 18 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee Of Shiraz University Of Medical Sciences
Street address
Shiraz University of Medical Sciences, Vice-Chancellors of Research and Technology, Zand Avenue, Shiraz
City
Shiraz
Postal code
1978-71345
Approval date
2017-02-06, 1395/11/18
Ethics committee reference number
IR.SUMS.REC.1395.29
Health conditions studied
1
Description of health condition studied
Bleeding during rhinoplasty
ICD-10 code
00
ICD-10 code description
00
Primary outcomes
1
Description
Hemoglobin concentration
Timepoint
Pre operatio and post operation
Method of measurement
Questionnaire Lab. (g/dL)
Secondary outcomes
1
Description
Transfused blood products
Timepoint
perioperatively
Method of measurement
number of units
2
Description
Hemoglobin
Timepoint
Post operative
Method of measurement
g/dL
3
Description
Blood Pressure
Timepoint
During administration
Method of measurement
Blood pressure monitoring
Intervention groups
1
Description
Intervention group: Patients in the interventional group (first group) will be received an intravenous VENOFER- iron sucrose injection, 500 mg dissolved in Norma salin 0.9 % via pump infusion bolus for 30 min. 25mg of Venofer should be infused over a period of 15 minutes. If no adverse events occur during the test dose, the remainder of the dose should be given at an infusion rate of not more than 50ml in 15 minutes.
Category
Treatment - Drugs
2
Description
Control group: Patients in the the second group will received " placebo" as same bolus volume dissolved in Norma salin 0.9 % in a 30-minute intravenous infusion.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz Rajaei Hospital
Full name of responsible person
Farhad Ghorbabi
Street address
Shiraz University Of Medical Sciences, Shiraz Rajaei Hospital, Chamran Blvd., Shiraz
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Medical Sciences
Full name of responsible person
Basir Hashemi
Street address
Shiraz University of Medical Sciences, Vice-Chancellery of Research and Technology, Zand Avenue, Shiraz
City
Shiraz
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, Shiraz 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
Shiraz School of Dentistry
Full name of responsible person
Saeed Tavanafar
Position
Resident of Maxillofacial Surgery
Other areas of specialty/work
Street address
Department of Maxillofacial Surgery, Shiraz School of Dentistry
City
Shiraz
Postal code
Phone
+98 71 3620 3709
Fax
Email
ghorbani14farhad@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz School of Dentistry
Full name of responsible person
Hamid Reza Eftekharian
Position
Associate Professor
Other areas of specialty/work
Street address
Shiraz University Of Medical Sciences, Shiraz Rajaei Hospital, Chamran Blvd., Shiraz
City
Shiraz
Postal code
7194815644
Phone
+98 71 3648 3783
Fax
+98 71 3624 8980
Email
eftekharhr@sums.ac.ir
Web page address
www.sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz School of Dentistry
Full name of responsible person
Hamid Reza Eftekharian
Position
Associate Professor
Other areas of specialty/work
Street address
Shiraz University Of Medical Sciences, Shiraz Rajaei Hospital, Chamran Blvd., Shiraz
City
Shiraz
Postal code
7194815644
Phone
+98 71 3648 3783
Fax
+98 71 3624 8980
Email
eftekharhr@sums.ac.ir
Web page address
www.sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)