Protocol summary

Summary
The objective of this study is to determine the effect of preoperative tranexamic acid administration on amount of blood loss during hysterectomy . This study, clinical trials, double-blind, placebo- control, single center are conducted in Arash women's hospital. Among women underwent hysterectomy 106 patient are entered in this study and randomly divided in two groups (by block randomization). Inclusion criteria: Uterine size <14 cm, hysterectomy for benign pathology, uterine prolapsed and abnormal uterine blooding. Exclusion criteria: History of previous myomectomy, coagulation disorder , history of abnormal coagulation test, thrombophilie, coagulopathy, cardiovascular, tromboemboli and ceasar, renal and liver dysfunction and patients with an allergy to tranexamic acid and BMI>30. Ten minute before surgery 10mg/kg tranexamic acid with 200 cc normal saline is injected Intravenously for intervention group. In control group 200 cc normal saline is administrated . Before and after surgery all of the surgery bands are weighted and the blood volume in suction devise is recorded . six and twenty four hours after hysterectomy, the hemoglobin will checked. Patients are checked for side effects of tranexamic acid (ceasar, peripheral vascular thrombosis, dizziness). All drugs are prepared by anesthesia technisian and patients are divided in two groups by a person who is not a member of the research group and members of this do not known about the kind of drugs .

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201306181951N3
Registration date: 2013-07-28, 1392/05/06
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-07-28, 1392/05/06
Registrant information
Name
Nasrin Faridi Tazeh-kand
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7788 3283
Email address
nfaridi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2013-07-23, 1392/05/01
Expected recruitment end date
2015-02-20, 1393/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of preoperative intravenous tranexamic acid adminstration on the amount of blood loss in women underwent hysterectomy
Public title
The effect of preoperative tranexamic acid adminstration on the amount of blood loss during hysterectomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Uterine size <14 cm, hysterectomy for benign pathology, uterine prolapsed and abnormal uterine blooding. Exclusion criteria: History of previous myomectomy, coagulation disorder , history of abnormal coagulation test, thrombophilie, coagulopathy, cardiovascular, tromboemboli and ceasar, renal and liver dysfunction and patients with an allergy to tranexamic acid and BMI>30.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 106
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Qods St, Keshavarz Blv
City
Tehran
Postal code
Approval date
2013-07-20, 1392/04/29
Ethics committee reference number
92-01-39-22126-89720

Health conditions studied

1

Description of health condition studied
blood loss during surgery
ICD-10 code
-
ICD-10 code description
-

Primary outcomes

1

Description
The amount of blood loss
Timepoint
Before surgery
Method of measurement
Before and after surgery all of the surgery bands are weighted and the blood volume in suction devise is recorded

2

Description
Side effects of tranexamic acid
Timepoint
During and after surgery
Method of measurement
questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:Ten minute before surgery 10mg/kg tranexamic acid with 200 cc normal saline is injected Intravenously.
Category
Treatment - Drugs

2

Description
The control group: Ten minute before surgery 200 cc normal saline is administrated.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Arash Women's Hospital
Full name of responsible person
Nasrin Faridi Tazeh-kand
Street address
Arash Women 's Hospital, Rashid Ave, Resalat Highway, Tehranparse,Tehran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences , Deputy of Research
Full name of responsible person
D.r Akbar Fotohi
Street address
Qods St, Keshavarz Blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences , Deputy of Research
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Arash Women 's Hospital , Tehran University of Medical Sciences
Full name of responsible person
Nasrin Faridi Tazeh-kand
Position
Assistant professor
Other areas of specialty/work
Street address
Arash Women 's Hospital, Rashid Ave, Resalat Highway, Tehranparse,Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 7771 9922
Fax
Email
nfaridi@sina.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arash Women 's Hospital , Tehran University of Medical Sciences
Full name of responsible person
Dr Nasrin Faridi Tazeh-kand
Position
Assistant professor
Other areas of specialty/work
Street address
Arash Women 's Hospital, Rashid Ave, Resalat Highway, Tehranparse,Tehran,Iran
City
Tehran
Postal code
Phone
+98 21 7771 9922
Fax
Email
nfaridi@sina.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arash Women 's Hospital , Tehran University of Medical Sciences
Full name of responsible person
Ladan Hosseini
Position
MS , Employee of research development center
Other areas of specialty/work
Street address
Arash Women 's Hospital, Rashid Ave, Resalat Highway, Tehranparse,Tehran.Iran
City
Tehran
Postal code
Phone
+98 21 7771 9922
Fax
Email
hosseiniladan@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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