Effect of Local Fibrinogen Administration on postoperative bleeding in open Prostatectomy surgery
Design
In this research, 44 eligible patients candidate for open Prostatectomy surgery were chosen and a code was allocated to each one of them. Then, patients were randomly divided into two control and intervention groups.
Settings and conduct
This study will be conducted in the Emam khomeini hospital general operating room. The Patients and surgeon will not be aware of the drug used and the division of the groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria are the Patients candidate for elective open prostatectomy surgery, Preoperative serum fibrinogen level between 2-4 g/l, ASA I,II , Age 45-70 years old. Exclusion criteria are the emergent or urgent surgery; Age more than 70 years or less than 45 years old; History of deep vein thrombosis; History of underlying hematologic disorders
Intervention groups
Drug:
Fibrinogen:
- Dose: 500 Milligram
- Number of using: Once
- Factory name: B Braun
- Manufacturing Country's Name: Germany
- Location prescribed: Local
- Administration time: End of Surgery.
Placebo:
Normal Saline:
- Dose: 10 milliliter
- Number of using: Once
- Factory name: Abureihan Corporation
- Manufacturing Country's Name: Iran
- Location prescribed: Local
- Administration time: End of Surgery
Main outcome variables
Bleeding during and after prostatectomy and the use of blood products will be recorded up to 24 hours after the operation.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170421033564N1
Registration date:2018-01-21, 1396/11/01
Registration timing:prospective
Last update:2018-01-21, 1396/11/01
Update count:0
Registration date
2018-01-21, 1396/11/01
Registrant information
Name
Mohammed Reza Ghandizadeh Dezfuli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3377 5494
Email address
ghandizadehdezfuli.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-03, 1397/01/14
Expected recruitment end date
2018-08-05, 1397/05/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Local Fibrinogen Administration on postoperative bleeding in open Prostatectomy surgery
Public title
Effect of Local Fibrinogen Administration on postoperative bleeding in open Prostatectomy surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria: Patients candidate for elective open prostatectomy surgery,
Preoperative serum fibrinogen level between 2-4 g/l,
ASA I,II ,
Age 45-70y
Exclusion criteria:
Exclusion criteria: Emergent or urgent surgery;
Age more than 70 years or less than 45 years old;
History of deep vein thrombosis;
History of underlying hematologic disorders
Age
From 45 years old to 70 years old
Gender
Male
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
44
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients will not have information about the categories of groups. The drug or placebo was prepared by a person who did not intervene in the surgery process and postoperative care.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Commitee of Ahvaz Jundishapur University of Medical Sciencses
Street address
No 3, University street, Golestan Blvd, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135785689
Approval date
2017-03-11, 1395/12/21
Ethics committee reference number
816.1395.rec.ajums.ir
Health conditions studied
1
Description of health condition studied
Benign Prostate Hypertrophy
ICD-10 code
N40
ICD-10 code description
Enlarged Prostate
Primary outcomes
1
Description
Bleeding during and after Prostatectomy surgery
Timepoint
End of surgery and 24 hours after surgery
Method of measurement
Observe
Secondary outcomes
1
Description
Volume of administered blood product
Timepoint
Twenty four hours after surgery
Method of measurement
Milliliter
Intervention groups
1
Description
Intervention group: Drug : Fibrinogen Dose: 500 mg Number of using: Once Factory name: CSL Behring Company Manufacturing Country's Name: USA Location prescribed: Local Administration time: End of Surgery
Category
Prevention
2
Description
Control group: Placebo: Normal Saline: Dose: 10 MilliliterNumber of using: OnceFactory name: Abureihan CompanyManufacturing Country's Name: IranLocation prescribed: LocalAdministration time End of surgery