Subconjunctival HemorrhageNCT04400916
Topical Tranexamic Acid After Intravitreal Injections
A study testing Tranexamic acid and Balanced Salt Solution in people with Subconjunctival Hemorrhage, run by Rambam Health Care Campus.
Trial summary
We aim to investigate whether topical administration of Tranexamic acid can reduce the occurence of subconjunctival hemorrahge after routine intravitreal injections for retinal conditions. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Subconjunctival Hemorrhage
- What is being tested?
- Tranexamic acid and Balanced Salt Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Sep 2020to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects receiving intravitreal injections as part of their routine ophthalmological care
Who cannot join
- Pregnancy, Oral contraceptives/HRT use, Known systemic autoimmune disease, Renal failure, active/suspected infection or inflammation in the treated eye, subconjunctival hemorrahge prior to inclusion, History of subarachnoid hemorrahge, thromboembolic events, increased risk for thromboembolic events, known sensitivity to the study drug
About this study
Official title: Topical Use of Tranexamic Acid for Prevention of Subconjunctival Hemorrhage After Intravitreal Injections
We aim to investigate whether topical administration of Tranexamic acid can reduce the occurence of subconjunctival hemorrahge after routine intravitreal injections for retinal conditions.
- Conditions
- Subconjunctival Hemorrhage
- Being tested
- Tranexamic acid, Balanced Salt Solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acidDrug
A single drop administered topically
Balanced Salt SolutionOther
A single drop administered topically
| Study group | Role | What they receive |
|---|---|---|
| Topical tranexamic acid | Experimental | Not described Receives: Drug: Tranexamic acid |
| Topical BSS | Placebo comparator | Not described Receives: Other: Balanced Salt Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subconjunctival hemorrahge
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2020
- Study startSep 2020 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subconjunctival HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shiri Soudry MD, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04400916
- Sponsor's protocol ID
- 0424-19-RMB
- Status last verified
- May 2020
- First submitted
- 20 May 2020
- Last updated
- 26 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Use of Tranexamic Acid for Prevention of Subconjunctival Hemorrhage After Intravitreal Injections
- ClinicalTrials.gov ID
- NCT04400916
- Acronym / sponsor ID
- 0424-19-RMB
- Conditions
- Subconjunctival Hemorrhage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Sep 2020 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 26 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We aim to investigate whether topical administration of Tranexamic acid can reduce the occurence of subconjunctival hemorrahge after routine intravitreal injections for retinal conditions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical tranexamic acid | Experimental | Drug: Tranexamic acid |
| Topical BSS | Placebo comparator | Other: Balanced Salt Solution |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects receiving intravitreal injections as part of their routine ophthalmological care
Key exclusion criteria (1 listed)
- Pregnancy, Oral contraceptives/HRT use, Known systemic autoimmune disease, Renal failure, active/suspected infection or inflammation in the treated eye, subconjunctival hemorrahge prior to inclusion, History of subarachnoid hemorrahge, thromboembolic events, increased risk for thromboembolic events, known sensitivity to the study drug
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic acidA single drop administered topically | Drug | Topical tranexamic acid |
| Balanced Salt SolutionA single drop administered topically | Other | Topical BSS |
Primary outcome
Subconjunctival hemorrahge
Time frame: 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Tranexamic acid and Balanced Salt Solution in people with Subconjunctival Hemorrhage, run by Rambam Health Care Campus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 May 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subconjunctival hemorrahge (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2020.