The evaluation of the effect of intravenous Tranexamic acid in reducing the amount of bleeding during external DCR (Dacryocyctorhinostomy) in patients with nasolacrimal duct obstruction ( NLDO) compared to control group
Reduction of bleeding during external dacryocystorhinostomy(DCR)
Design
Clinical trial with control group, double-blind, randomized, phase 3 on 70 patients, pass software was used for randomization.
Settings and conduct
This study is performed on patients with nasolacrimal duct obstruction. The surgery is performed by a single skilled surgeon in Khatam Al-Anbia Ophthalmology Hospital in Mashhad. The study is double blind. The researcher and evaluator will be blinded in this study. The method of blinding is that the evaluator and researcher are unaware of the patients in the intervention and control groups.
Participants/Inclusion and exclusion criteria
Patients with nasolacrimal duct obstruction(NLDO) who don't have a history of coagulation disorders; Covid-19 infection and trauma to the lacrimal drainage system are included in the study.
Intervention groups
In the intervention group, 10 mg per kg intravenous tranexamic acid will be injected, 30 minutes before surgery. In the control group, surgery will be performed without placebo.
Main outcome variables
the amount of bleeding
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211121053138N1
Registration date:2021-12-01, 1400/09/10
Registration timing:prospective
Last update:2021-12-01, 1400/09/10
Update count:0
Registration date
2021-12-01, 1400/09/10
Registrant information
Name
samaneh gholamhoseinpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3844 0459
Email address
gholamhoseinpoursamaneh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-21, 1400/09/30
Expected recruitment end date
2022-09-20, 1401/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of the effect of intravenous Tranexamic acid in reducing the amount of bleeding during external DCR (Dacryocyctorhinostomy) in patients with nasolacrimal duct obstruction ( NLDO) compared to control group
Public title
The evaluation of the effect of intravenous Tranexamic acid in external DCR (Dacryocyctorhinostomy)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with nasolacrimal duct obstruction
Exclusion criteria:
Any history of trauma to lacrimal drainage system
History of coagulopathy state
History of bleeding disorders
History of Covid-19 in the last 6 months
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Investigator
Outcome assessor
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization of the structure will be performed using the sequence generated by PASS statistical software. The generated sequences are placed in closed envelopes in order so that their contents are not visible from the outside and an envelope will be allocated for each patient who agrees to participate in the project, respectively. Eventually the patient will be randomly placed in the control or intervention group
Blinding (investigator's opinion)
Double blinded
Blinding description
The study will be double blind. Impact assessor will be blinded to type
intervention and the researcher who must enter the data into the checklist
will be blinded to the type of intervention
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Medicine- Mashhad University of Medical Sciences
Street address
No. 53 Beheeshti Ave, Kohsangi Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9175914785
Approval date
2021-11-01, 1400/08/10
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1400.520
Health conditions studied
1
Description of health condition studied
nasolacrimal duct obstruction
ICD-10 code
H0405
ICD-10 code description
Stenosis and insufficientcy of lacrimal passages
Primary outcomes
1
Description
Record the amount of intraoperative bleeding at external dacryocyctorhinostomy
Timepoint
at the end of surgery
Method of measurement
The amount of bleeding recorded by a standard suction device in a calibrated tank.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Tranexamic acid will be injected intravenously only once, at a dose of 10 mg per kilo, half an hour before surgery. The manufacturer of the drug is CASPIAN TAMIN
Category
Treatment - Drugs
2
Description
Control group: no placebo will be injected.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam-Al-Anbia hospital
Full name of responsible person
Samaneh Gholamhosseinpour-Omran
Street address
No.41 Gharani Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9175914785
Phone
+98 51 3728 1400
Email
gholamhoseinpoursamaneh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Maliheh Dadgar Moghadam
Street address
No. 41 Gharani
City
Mashhad
Province
Razavi Khorasan
Postal code
9175914785
Phone
+98 51 3841 2081
Email
dadgarmoghaddamm@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Samaneh Gholamhosseinpour-Omran
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
No. 53 Beheshti Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9175914785
Phone
+98 51 3844 0459
Email
gholamhoseinpoursamaneh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Samaneh Gholamhosseinpour-Omran
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
No. 53 Beheshti Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9175914785
Phone
+98 51 3844 0459
Email
gholamhoseinpoursamaneh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Samaneh Gholamhosseinpour-Omran
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
No. 53 Beheshti 53 Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9175914785
Phone
+98 51 3844 0459
Email
gholamhoseinpoursamaneh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD