Investigating the relationship between intravenous iron injection before spinesurgery in patients and improving perioperative outcomes, a randomized clinical trila.
intravenous iron injection before spine surgery in patients and improving the outcome around the action
Design
Clinical trial with a control group with parallel double-blind groups, phase 3 on 60 patients. K-S test was used to check the distribution of quantitative data. Chi-square test used to study the relationship between qualitative variables.
Settings and conduct
After going through legal procedures to access patient information and with the commitment not to disclose secrets
Patients, permission to access the patients' files was obtained. This research is in the form of a work study A double-blind randomized clinical trial was conducted on patients who were candidates for spine surgeryTajrish Hospital performed. Patients classified into three groups (A), (B) and (C).Group (A) patients, have hemoglobin less than 13mg/dl in men and hemoglobin less than 12mg/dl in women and iron injection before surgery they received. Group (B) patients, had hemoglobin in the normal range They received an injection before the operation.group c have not recieved IV Iron. Injectable iron is used in the form of 500 mg in 1000 cc of normal saline, which is injected within 15 minutes to 1 hour. The iron is VENOFER type.
Participants/Inclusion and exclusion criteria
Exclusion criteria: patients who were allergic to iron, patients under 18 years old and over 70 years old. active infection, known hemosiderosis, known thalassemia major and intermedia, known nutrition in the acute phase of nutritional recovery, ferritin more than 300 ng/ml, and those categories Patients who did not consent.
Inclusion criteria: patients undergoing posterior lumbar fusion surgery in at least 3 levels
Intervention groups
patients undergoing posterior lumbar fusion surgery in at least 3 levels
Main outcome variables
Infection, hospitalization, hemoglobin drop,The degree of welding of the beads
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230815059152N1
Registration date:2023-09-11, 1402/06/20
Registration timing:retrospective
Last update:2023-09-11, 1402/06/20
Update count:0
Registration date
2023-09-11, 1402/06/20
Registrant information
Name
Farzan Fahim
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2680 0765
Email address
farzn.fahim@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-24, 1402/03/03
Expected recruitment end date
2023-07-22, 1402/04/31
Actual recruitment start date
2023-05-26, 1402/03/05
Actual recruitment end date
2023-07-23, 1402/05/01
Trial completion date
empty
Scientific title
Investigating the relationship between intravenous iron injection before spinesurgery in patients and improving perioperative outcomes, a randomized clinical trila.
Public title
Investigating the effect of intravenous iron injection in spine surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range from 18 to 70years
Patients undergoing posterior vertebral fusion surgery at least 3 levels
Exclusion criteria:
History of iron sensitivity
Under 18 years and over 70 years
known Cirrhosis of the liver
known Thalassemia major
Ferritin more than 300 ng/dl
known Thalassemia Intermedia
known Hemosiderosis
known Active phase of nutritional deficiency
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Care provider
Data analyser
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
The aforementioned study is a double-blind clinical trial, as follows:
1) The statistical analyst is outside the treatment team, and it is not clear to them whether group A, B or C has been subjected to intervention and the information of each of the three groups without being told in which of the groups the intervention took place. has been accepted and will be available to them.
2) The neurosurgery assistant present during the operation, (who is present as a clinical supervisor)so that all three groups of patients will undergo posterior instrumentation surgery, as well as the same surgical technique and the possibility of deviation by the surgeon during the operation, they are informed that this The patients are in the study, but they are not told which of the patients have undergone intravenous iron injection and intervention.
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Volenjek St., in front of the fire station, corner of 16th St., Nirvana Building, No. 1
City
Tehran
Province
Tehran
Postal code
1985743855
Approval date
2023-08-27, 1402/06/05
Ethics committee reference number
IR.SBMU.MSP.REC.1402.219
Health conditions studied
1
Description of health condition studied
After posterior fusion surgery of lumbar vertebrae
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Duration of hospitalization after surgery
Timepoint
The beginning of the study and the end of the study
Method of measurement
Counting down the days
2
Description
Incidence of infection
Timepoint
Day 0 until the end of hospitalization
Method of measurement
Qualitative
3
Description
The degree of fusion of the vertebrae with an interval of one month after the operation
Timepoint
one month after the operation
Method of measurement
lenke scale
4
Description
Hemoglobin drop after surgery
Timepoint
Immediately after surgery, 14 days and then 28 days after surgery
Method of measurement
laboratory
Secondary outcomes
empty
Intervention groups
1
Description
The patients in the mentioned clinical trial study are in three groups (A), (B) and (C). All the patients who entered the Madaleh have signed a written consent form to perform the intervention and have received full explanations. Group (a) are those patients who have anemia in laboratory results before surgery, i.e. hemoglobin less than 13 gm/dL for men and less than 12 mg/dL for women. and they are supposed to undergo the intervention of intravenous iron injection. Group (b) are those patients who do not have anemia in laboratory tests before surgery and are supposed to undergo the intervention of intravenous iron injection,Group (c) is the control group that does not undergo the intervention of intravenous iron injection.Venofer intravenous iron comes in the form of vials containing 500 mg of iron, which is injected into the patient in 1000 cc of normal saline over a period of 15 minutes to 1 hour. Intravenous iron injection is done 24 hours before surgery in these patients. Before the injection, the patients' hemoglobin and ferritin levels are checked and recorded in laboratory tests. After surgery, laboratory tests are repeated at intervals of 1 day, 14 days, and then 28 days, and their levels are also recorded. Also, during hospitalization, patients are checked for the occurrence of infection at the operation site and also the duration of hospitalization. On the 28th day, the patients undergo a routine follow-up CT scan or a simple photo of the abdomen, and with the help of the Lenke criteria, we can classify the degree of swelling of the patients.All information and data are presented to a statistical expert for analysis. It should be noted that the statistical analyst is outside the treatment team and is blinded to the intervention. Also, neurosurgery assistants who are present during the surgery to prevent bias. The precision and technique during the operation is blind to the intervention.
بزرگراه تهران- شهید چمران - خیابان یمن - خیابان اعرابی- نرسیده به بیمارستان آیت الله طالقانی- دانشگاه علوم پزشکی و خدمات بهداشتی درمانی شهید بهشتی ساختمان شماره دو ستاد دانشگاه- طبقه ششم
City
Tehran
Province
Tehran
Postal code
4631- 19395.
Phone
+98 21 2243 9788
Email
urm@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
farzan fahim
Position
medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Nirvana Building, No. 1, corner of 16th St., in front of the fire station, Volenjak St.
City
Tehran
Province
Tehran
Postal code
1985743855
Phone
+98 21 2680 0765
Email
farzn.fahim@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
farzan fahim
Position
medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Nirvana Building, No. 1, corner of 16th St., in front of the fire station, Volenjak St.
City
Tehran
Province
Tehran
Postal code
1985743855
Phone
+98 21 2680 0765
Email
farzn.fahim@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
farzan fahim
Position
medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Nirvana Building, No. 1, corner of 16th St., in front of the fire station, Volenjak St.
City
Tehran
Province
Tehran
Postal code
1985743855
Phone
+98 21 2680 0765
Email
farzn.fahim@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Duration of hospitalization from before operation to after
Number of operated tubes
Is there an infection at the surgical site or not?
What was the initial and final hemoglobin level? Has it dropped or not? Are the changes meaningful?
When the data will become available and for how long
From 1403
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
Natural and legal persons with university faculty status
From where data/document is obtainable
Farzan Fahim, mobile number 09120943182, email address farzn.fahim@gmail.com
What processes are involved for a request to access data/document
First, send an email with your complete introduction, then the answer will be sent within 24 hours.