1. Home
  2. Approved trials
  3. » فارسی

The effects of local tranexamic acid on reducing of intra and post external dacryocystorhinostomy hemorrhage in patients with primary acquired nasolacrimal duct abstruction

Protocol summary

Study aim
Determine the Effectiveness of Local Tranexamic Acid on Reducing of intra and post external Dacryosystorhinosity hemorrhage in Patients with Primary Acquired Obstruction of Nasolacrimal Duct
Design
Phase 3 clinical trial, double-blind randomized, control group, parallel groups, sample size 126, randomization of quadruple computer blocks
Settings and conduct
This study will be conducted at the Amiralmomenin Medical Center of Rasht.After obtaining informed consent from patients, four groups of randomized blocks will be studied in two intervention and control groups.After the patient is ready for surgery,the desired solution and placebo are injected in the surgical site (0.5 ml in the posterior region, 0.5 ml in the superior and in the inferior, and 0.5 ml in the infra orbital nerve).The bleeding from the surgical site by suction blood volume assessment and surgeon satisfaction of the surgical field numerically 1: good, 2: moderate and 3: Bad evaluated in two groups.
Participants/Inclusion and exclusion criteria
Entry requirements: patients over 50 years of age with primary and acquired obstruction of the nasolacrimal duct of the candidate for surgery dacryosisturinostomy (DCR). Non-arrival conditions: any disturbances in coagulation tests.
Intervention groups
In the intervention group, the following combination is injected at the surgical site: 3.5 ml Bupivaine 5%, 4 ml Lidocain 2%, 0.1 Adrenalin 1/100000, 2.5 ml Tranexamic Acid In the control group, the following combination is injected at the surgical site: 3.5ml Bupivaine 5%, 4ml Lidocain 2% , 0.1 Adrenalin 1/100000,Normal saline 0.05 ml/kg
Main outcome variables
Reduce the amount of bleeding during surgery

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20140310016917N6
Registration date: 2018-10-16, 1397/07/24
Registration timing: retrospective

Last update: 2018-10-16, 1397/07/24
Update count: 0
Registration date
2018-10-16, 1397/07/24
Registrant information
Name
Ali Ashraf
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1321 0434
Email address
aliashraf@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-06, 1397/06/15
Expected recruitment end date
2018-09-21, 1397/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of local tranexamic acid on reducing of intra and post external dacryocystorhinostomy hemorrhage in patients with primary acquired nasolacrimal duct abstruction
Public title
The effects of local tranexamic acid on dacryocystorhinostomy hemorrhage
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with primary and acquired obstruction of the nasolacrimal duct undergo surgery for dacryosisturinostomy under local anesthesia
Exclusion criteria:
Coagulation disorders Age less than 50 years Surgery with general anesthesia Allergic reaction to lidocaine or tranexamic acid Uncontrolled hypertension History of anticoagulation History of thromboembolic disease and thrombophilia Hemoglobin is less than 10
Age
From 50 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
Sample size
Target sample size: 126
Actual sample size reached: 126
Randomization (investigator's opinion)
Randomized
Randomization description
Quadruple random blocks using statistical software
Blinding (investigator's opinion)
Double blinded
Blinding description
Participant: the patient is unaware of the type of local drug combination. Clinical care: the person administering the drug is unaware of the presence of tranexamic acid. Evaluation of outcomes: the type of drug combination is not known and only measures the amount of bleeding.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Guilan university of Medical Sciences
Street address
Namjoo street
City
Rasht
Province
Guilan
Postal code
4193893345
Approval date
2018-09-22, 1397/06/31
Ethics committee reference number
IR.GUMS.REC.1397.242

Health conditions studied

1

Description of health condition studied
Congenital and secondary stenosis and stricture of lacrimal duct
ICD-10 code
Q10.5
ICD-10 code description
Congenital stenosis and stricture of lacrimal duct

Primary outcomes

1

Description
Reduced bleeding during surgery
Timepoint
During and after the surgery
Method of measurement
Suctioned blood volume and quality of the surgical field surgeon

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 3.5ml Bupicaine 5%, 4ml Lidocain 2%, 0.1ml Aderenalin 1/100000,2.5ml Tranexamic Acid
Category
Treatment - Drugs

2

Description
Control group: 3.5ml Bupicaine 5%, 4ml Lidocain 2%, 0.1ml Aderenalin 1/100000,Normal salin 0.05 ml/kg
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Amiralmoemenin hospital
Full name of responsible person
Ali Ashraf
Street address
Dr. Heshmati Square., Shahrivar St.
City
Rasht
Province
Guilan
Postal code
41937-13194
Phone
+98 13 3323 6886
Fax
+98 13 3323 6886
Email
crdu.Poursina@gums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Shadman Nemati
Street address
Namjoo street, shahid siyadati street
City
Rasht
Province
Guilan
Postal code
41937-13194
Phone
+98 13 3333 6394
Fax
+98 13 3333 6395
Email
research@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
Ali Ashraf
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Prastar street
City
Rasht
Province
Guilan
Postal code
41937-13194
Phone
+98 13 3332 2250
Fax
Email
aliashraf@gums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Ali Ashraf
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Parastar street
City
Rasht
Province
Guilan
Postal code
41937-13194
Phone
+98 13 3332 2250
Email
aliashraf@gums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Ali Ashraf
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Parastar street
City
Rasht
Province
Guilan
Postal code
41937-13194
Phone
+98 13 3332 2250
Email
aliashraf@gums.ac.ir

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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
It will be published as a scientific article
When the data will become available and for how long
A year after the publication of the article
To whom data/document is available
Researchers working in academia and academia
Under which criteria data/document could be used
There is no item
From where data/document is obtainable
aliashraf@gums.ac.ir
What processes are involved for a request to access data/document
aliashraf@gums.ac.ir
Comments
Loading...