In this study we will assess whether the prophylactic fibrinogen administration before radical cyctectomy would decrease bleeding during surgery or not
Design
Two arm parallel group randomised trial with blinded postoperative care and outcome assessment
Settings and conduct
All patients are blinded and anesthesiologist will only know who had received fibrinogen
Participants/Inclusion and exclusion criteria
All patients with bladder cancer who are candidates for elective radical cyctectomy are included
exclusion criteria are:
Anticoagulant agent
Having a known blood Abnormality or coagulopathy
A history of thromboembolism
Chronic liver disease
Chronic kidney disease
A preoperative plasma fibrinogen level of ≥ 400 mg/dl
Intake of non-steroidal anti-inflammatory drugs within 2 days
prior to surgery
Intervention groups
Patients in study group will receive 2 grams of fibrinogen and in control group will receive 100 cc normal saline
Main outcome variables
amount of bleeding during surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191013045091N1
Registration date:2020-01-30, 1398/11/10
Registration timing:registered_while_recruiting
Last update:2020-01-30, 1398/11/10
Update count:0
Registration date
2020-01-30, 1398/11/10
Registrant information
Name
Mohsen Arian nik
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4447 7493
Email address
m.ariannik@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-15, 1398/09/24
Expected recruitment end date
2020-03-15, 1398/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Prophylactic Fibrinogen effect on perioperative bleeding in radical cystectomy: a double-blind randomized placebo-controlled study
Public title
Prophylactic Fibrinogen and perioperative bleeding
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients older than 18 years old
Admitted for elective radical cystectomy
localized bladder cancer (T1–2N0M0)
Exclusion criteria:
Anticoagulant agent
Having a known blood Abnormality or coagulopathy (abnormal values of platelet count, PT, APTT, fibrinogen, antithrombin, or Ddimer)
A history of thromboembolism
Chronic liver disease
Chronic kidney disease with a serum creatinine level of > 2 mg/dl
A preoperative plasma fibrinogen level of ≥ 400 mg/dl
intake of non-steroidal anti-inflammatory drugs within 2 days prior to surgery
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
35
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Random Sampling using table of random numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
the study group will receive 2 grams of fibrinogen in 100 cc of distilled water by an anesthetist 30 min before surgery and control group will receive the same amount of normal saline, the anesthesiologist will know only the patients who had received fibrinogen
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences