Determining the effect of intravenous fibrinogen administration on reducing bleeding during pelvic joint replacement.
Design
Clinical trial with control group, with parallel groups, double-blind, randomized with dice tose, phase 2 on 110 patients
Settings and conduct
After obtaining informed consent from patients over 18 years of age who are candidates for primary pelvic joint replacement surgery in the operating room of Imam Hossein Hospital in Tehran, patients with uncontrolled underlying disease, previous surgical history in the current operation field, substance abuse, and recent history of coagulation disease or use of anticoagulants prior to hospitalization will be excluded from the study. In the fibrinogen group, patients receive 1 gram of this drug in 50 ml of distilled water through an infusion pump over ten minutes. In the control group, 50 ml of distilled water will be used in the same way as above. An anesthesia technician selects one of the syringes containing fibrinogen or placebo for the patient without informing the anesthesiologist and the patient. The questionnaire is delivered to the first technician.
Participants/Inclusion and exclusion criteria
Patients over 18 years of age who are candidates for primary hip replacement surgery in the operating room of Imam Hossein Hospital in Tehran will be examined after obtaining informed consent. Current operating range, substance use, and recent history of coagulation disease or use of anticoagulants prior to hospitalization will be excluded.
Intervention groups
In the fibrinogen group (case), patients will receive one gram of this drug in a volume of 50 ml of distilled water through an infusion pump within ten minutes of intravenous injection. In the control group, 50 ml of distilled water will be used in the same way as above.
Main outcome variables
Bleeding during surgery
Postoperative bleeding
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120910010800N3
Registration date:2022-04-05, 1401/01/16
Registration timing:prospective
Last update:2022-04-05, 1401/01/16
Update count:0
Registration date
2022-04-05, 1401/01/16
Registrant information
Name
Dariush Abtahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2263 2611
Email address
d.abtahi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-22, 1401/03/01
Expected recruitment end date
2022-09-23, 1401/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining the preventive effect of venous fibrinogen on the amount of bleeding during hip arthroplasty surgery
Public title
Determining the preventive effect of venous fibrinogen on the amount of bleeding during hip arthroplasty surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
over than 18 years old
Consent to the study
Exclusion criteria:
Drug abuse
Existence of uncontrolled underlying disease
History of any previous surgery within the field of the current operation
Recent history of coagulation disease
Taking drugs that affect blood clotting before hospitalization
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are grouped among the people referring to the operating room of Imam Hossein Hospital (AS) for hip arthroplasty surgery by simple randomization method using coin toss. In such a way that the selection of the case is done in case of tap and the selection of control is done in case of line.
Blinding (investigator's opinion)
Double blinded
Blinding description
Before anesthesia, the other anesthesia technician selects one of the syringes containing fibrinogen (case group) or placebo (control group) for the patient without the knowledge of the anesthesiologist and the patient. After general anesthesia, the infusion is started for all patients. After the surgery, the questionnaire is delivered to the first technician.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Vice-Chancellor in Research Affairs - Shahid Beheshti University
Street address
Emam Hossein Hospital, Shahid Madani St.
City
Tehran
Province
Tehran
Postal code
1617763141
Approval date
2022-03-13, 1400/12/22
Ethics committee reference number
IR.SBMU.RETECH.REC.1400.1221
Health conditions studied
1
Description of health condition studied
Total hip arthroplasty
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Bleeding during surgery
Timepoint
End of surgery
Method of measurement
The amount of bleeding during the operation will be measured by gas count and suction measurement, as well as the estimation of bleeding at the operation site by an anesthesiologist.
Secondary outcomes
1
Description
Number of units of injected blood products
Timepoint
Up to 24 hours after surgery
Method of measurement
Registration of blood products injection sheet
Intervention groups
1
Description
Intervention group: After induction of anesthesia, one vial of fibrinogen powder equivalent to one gram of it under the brand name HAEMOCOMPLETTAN P Injection, Powder 1 g made by CSL BEHRING company in Germany with 50 ml of distilled water to minimize foam production in the vial It is diluted. The entire amount is drawn into a 50 ml syringe and then injected intravenously using an infusion pump over ten-minutes in a single dose.
Category
Treatment - Drugs
2
Description
Control group: After induction of anesthesia, 50 ml of distilled water is drawn in a 50 ml syringe and then injected intravenously using an infusion pump for ten minutes as a single dose.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospital Emam Hossein
Full name of responsible person
Dariush Abtahi
Street address
Shahid Madani St
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7756 7840
Email
drdariushabtahi@yahoo.com
Web page address
https://www.ehmc.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshhin Zarghi
Street address
Velenjak، 7th Floor, Bldg No.2 SBUMS, Arabi Ave
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2243 9770
Email
Intl_office@sbmu.ac.ir
Web page address
https://en.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
Dariush Abtahi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid Madani St
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
009821277567840
Email
drdariushabtahi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dariush Abtahi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid Madani St.
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
009812277567840
Email
drdariushabtahi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dariush Abtahi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid Madani St.
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
009812277567840
Email
drdariushabtahi@yahoo.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
No - There is not a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All data is potentially shareable after unidentified individuals.
When the data will become available and for how long
One year after the publication of the article.
To whom data/document is available
All jobs
Under which criteria data/document could be used
All non-personal patient information (anonymously) can be accessed by contacting the responsible author.
From where data/document is obtainable
email to: drdariushabtahi@yahoo.com
What processes are involved for a request to access data/document
Sending email and review by the responsible author.