The effect of fibrinogen prophylactic injection on bleeding during pelvic surgery
Design
A randomized controlled clinical trial with parallel, double-blind, randomized groups
Settings and conduct
Forty-four patients were randomly divided into 21 groups of fibrinogen and placebo. Hemoglobin, platelet and fibrinogen levels are measured in all patients before surgery. In the intervention group after induction, one gram of fibrinogen is injected and the control group is injected with a similar amount in ml of normal saline.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients candidate for non-emergency pelvic surgery undergoing general anesthesia.
Intervention groups
In the intervention group after induction, one gram of fibrinogen is injected and the control group is injected with a similar amount in ml of normal saline.
Main outcome variables
Plasma fibrinogen
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200109046064N1
Registration date:2020-02-11, 1398/11/22
Registration timing:prospective
Last update:2020-02-11, 1398/11/22
Update count:0
Registration date
2020-02-11, 1398/11/22
Registrant information
Name
Majid Charosaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4407 6824
Email address
drch128@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-20, 1398/12/01
Expected recruitment end date
2020-04-20, 1399/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Prophylactic Fibrinogen Infusion on intraoperative bleeding during Pelvic Surgery
Public title
Effect of fibrinogen on bleeding during pelvic surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients candidate for non-emergency pelvic surgery undergoing general anesthesia
Satisfaction with study participation
Age between 18-60
BMI<30
The preoperative fibrinogen level should be 2-4 g/lit
Exclusion criteria:
cardiovascular, liver, kidney, coagulation and hypertension disorders, diabetes and tumors in surgical areas.
History of use the Beta-Blocker, Calcium Blocker, Digoxin, Tricyclic Antidepressants, Anti-Coagulant and Clonidine
A history of alcohol, drug and drug abuse
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Using the random number table and quadruple blocks, the following states are obtained and individuals in group A receive fibrinogen and those in group B receive placebo. The above cases include ABAB, AABB, BAAB, BABA, BBAA, ABBA, which are put together by four blocks of states that are completely random and are randomly divided into patients.
Blinding (investigator's opinion)
Double blinded
Blinding description
To blind and hide the specimens, a special code was written for each patient in a sealed envelope that only by a researcher opened the envelope just prior to attempting to anesthetize the patient in complete confidentiality
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Next to Milad Tower, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2018-04-29, 1397/02/09
Ethics committee reference number
IR.IUMS.FMD.REC.1396.9511174006
Health conditions studied
1
Description of health condition studied
Pelvic Surgery
ICD-10 code
S32.7
ICD-10 code description
Multiple fractures of lumbar spine and pelvis
Primary outcomes
1
Description
Plasma fibrinogen
Timepoint
Before and after surgery
Method of measurement
Based on the patient's blood laboratory results
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Before surgery, one gram of prophylactic fibrinogen infusion (made by the Marburg factory in Germany) is performed in 50 ml of normal saline within five minutes after induction of anesthesia.
Category
Treatment - Drugs
2
Description
Control group: Before surgery, normal saline infusion is performed.