Comparison of Effect of Topical Transamic Acid and Systemic Prednisolone in Preventing Rebleeding in Patients with Traumatic Hyphaemia
Design
Intention to treat one-way blind clinical trial with parallel groups, phase 2, dividing 101 patients into two groups at random and giving Prednisolone 1 mg / kg daily in two divided doses to one group and Transamic Acid 5% was given to another group every 6 hours until clot absorbed or up to 5 days (whichever occurred earlier) to randomize sequencing using PASS software. Allocation concealment was also done through envelopes
Settings and conduct
This study includes treatment of Patients with Traumatic Hyphema by systemic Prednisolone and topical Tranexamic acid. 101 patients with traumatic hyphema who were admitted in the "Khatam Alanbia Hospital" in Mashhad. 44 persons with tranexamic acid treatment and 57 persons with prednisolone treatment.
Participants/Inclusion and exclusion criteria
Acceptance criteria: Patients with Traumatic Hyphema referred to Mashhad Eye "Khatam AlAnbia Hospital"
Exclusion criteria: Microscopic hyphema,Patients with systemic diseases such as diabetes mellitus, hypertension and coagulopathies who taking anticoagulants drugs, patients who have a history of ophthalmic surgery, children under 7years old, and pregnant women.
Intervention groups
Topical administration of Transamic Acid 5% every 6 hours and systemic prednisolone 1 mg / kg in two divided doses for 5 days or until clot absorption (whichever occurs earlier) in each group
Main outcome variables
Rebleeding in patients with traumatic hyphema
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201110049345N1
Registration date:2020-12-01, 1399/09/11
Registration timing:retrospective
Last update:2020-12-01, 1399/09/11
Update count:0
Registration date
2020-12-01, 1399/09/11
Registrant information
Name
Javad Firoozi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3879 0810
Email address
firoozij951@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
2018-08-23, 1397/06/01
Actual recruitment end date
2020-02-20, 1398/12/01
Trial completion date
2020-03-19, 1398/12/29
Scientific title
Comparison of the Effect of Systemic Prednisolone and Topical Tranexamic Acid on Prevention of Rebleeding in Patients with Traumatic Hyphema
Public title
Effect of Systemic Prednisolone and Topical Tranexamic Acid on Prevention of Rebleeding in Traumatic Hyphema
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Traumatic Hyphema referred to Mashhad Eye "Khatam AlAnbia Hospital"
Exclusion criteria:
Microscopic hyphema
Globe rupture
Patients with systemic diseases such as diabetes mellitus, hypertension
Posterior segment pathology except commotio retina
coagulopathy and taking anticoagulants drugs
history of ophthalmic surgery
children under 7years old
pregnant women.
Age
From 7 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Actual sample size reached:
101
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomize, sequence production was performed using PASS software. Allocation concealment was also done through envelopes.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants randomly divided in two groups by random table numbers and take medications.outcome assessors and data analysers don’t informed about goal of study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad university of medical science.
Street address
Knowledge and Health City of Mashhad university of medical science – In the end of Shahid Fakouri Blvd (In front of Fakouri 94) – Mashhad - Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Approval date
2018-08-18, 1397/05/27
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1398.519
Health conditions studied
1
Description of health condition studied
Hyphema
ICD-10 code
H21.0
ICD-10 code description
Hyphema
Primary outcomes
1
Description
Rebleeding
Timepoint
Daily for 5 days and two weeks later.
Method of measurement
Slit lamp biomicroscopy
Secondary outcomes
empty
Intervention groups
1
Description
Patients with traumatic hyphema recived Topical Tranzamic Acid5% made by sterilization specialists of Mashhad University of Medical Sciences were administered every 6 hours for 5 days or until clot absorption (each occurred earlier).
Category
Prevention
2
Description
Patients with traumatic hyphema who were given prednisolone tablets at a dose of 1 mg / kg for 5 days or until clot absorption (whichever occurs earlier).
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam Al Anbia hospital
Full name of responsible person
Javad Firoozi
Street address
Gharani Blv,Mashhad town
City
Mashhad
Province
Razavi Khorasan
Postal code
9774117737
Phone
+98 51 3728 1400
Email
Firoozij951@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Khalil Abnous
Street address
Ghoreyshi building, Daneshgah Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Phone
+98 51 3845 2474
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?