Nasolacrimal Tract ObstructionTA-DCRNCT01221909
Tranexamic Acid in Dacryocystorhinostomy
A study testing Tranexamic acid and saline solution in people with Nasolacrimal Tract Obstruction, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
Single dose tranexamic acid (TA) before dacryocystorhinostomy (DCR) operation: a prospective, double blind, placebo controlled study. The study hypothesis: TA in DCR might reduce the intraoperative and postoperative bleeding in DCR surgery, and might reduce the duration of the surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasolacrimal Tract Obstruction
- What is being tested?
- Tranexamic acid and saline solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2010to Dec 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- obstruction of nasolacrimal pathway
- eligible for DCR surgery
- 18 years of age or older
Who cannot join
- warfarin treatment
- renal insufficiency
- pregnancy
- mental retardation
- tendency to bleed
- thromboembolic disease
- thrombophilia
Trial locations and contacts
1 site in 1 country.
Israel1 site
Dept. of Ophthalmology, HaEmek medical center
Afula, Afula, 18101
Haneen Jabaly-Habib, M.D., 972-506268059, hjabaly@gmail.com
Abed Mukari, M.D., 972-546881532, amukari@gmail.com
About this study
Official title: Single Dose Tranexamic Acid for Dacryocystorhinostomy
Single dose tranexamic acid (TA) before dacryocystorhinostomy (DCR) operation: a prospective, double blind, placebo controlled study.
The study hypothesis: TA in DCR might reduce the intraoperative and postoperative bleeding in DCR surgery, and might reduce the duration of the surgery.
- Conditions
- Nasolacrimal Tract Obstruction
- Being tested
- Tranexamic acid, saline solution
- Keywords
- bleeding, dacryocystorhinostomy, operative duration
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acidDrug
Single dose TA 500mg or placebo will be given in DCR surgery right after the first surgical incision.
saline solutionDrug
5cc saline solution
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic acid single dose of 500mg | Experimental | Not described Receives: Drug: Tranexamic acid |
| Saline | Placebo comparator | Not described Receives: Drug: saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of DCR surgery in minutes and amount of blood loss in milliliters during surgery.
Measured: Blood loss will be measured at the end of DCR operation from the suction bowel. Duration of surgery will be caculated by registering time of operation start and end.
Secondary outcomes (1)
Late onset postoperative epistaxis or periorbital hematoma
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2010 (estimated)
- Study startDec 2010
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Nasolacrimal Tract ObstructionStudies 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01221909
- Sponsor's protocol ID
- EMC-DCR-TA
- Acronym
- TA-DCR
- Status last verified
- Oct 2010
- First submitted
- 18 Sep 2010
- Last updated
- 15 Oct 2010
- Results posted
- No
Publications
Ralley FE, Berta D, Binns V, Howard J, Naudie DD. One intraoperative dose of tranexamic Acid for patients having primary hip or knee arthroplasty. Clin Orthop Relat Res. 2010 Jul;468(7):1905-11. doi: 10.1007/s11999-009-1217-8. Epub 2010 Jan 9.
PubMed 20063079Wellington K, Wagstaff AJ. Tranexamic acid: a review of its use in the management of menorrhagia. Drugs. 2003;63(13):1417-33. doi: 10.2165/00003495-200363130-00008.
PubMed 12825966Astedt B. Clinical pharmacology of tranexamic acid. Scand J Gastroenterol Suppl. 1987;137:22-5.
PubMed 3321402
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Dose Tranexamic Acid for Dacryocystorhinostomy
- ClinicalTrials.gov ID
- NCT01221909
- Acronym / sponsor ID
- TA-DCR / EMC-DCR-TA
- Conditions
- Nasolacrimal Tract Obstruction
- Keywords
- bleeding, dacryocystorhinostomy, operative duration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 15 Oct 2010 (estimated)
- 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.
Single dose tranexamic acid (TA) before dacryocystorhinostomy (DCR) operation: a prospective, double blind, placebo controlled study.
The study hypothesis: TA in DCR might reduce the intraoperative and postoperative bleeding in DCR surgery, and might reduce the duration of the surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid single dose of 500mg | Experimental | Drug: Tranexamic acid |
| Saline | Placebo comparator | Drug: saline solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- obstruction of nasolacrimal pathway
- eligible for DCR surgery
- 18 years of age or older
Key exclusion criteria (7 listed)
- warfarin treatment
- renal insufficiency
- pregnancy
- mental retardation
- tendency to bleed
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 acidSingle dose TA 500mg or placebo will be given in DCR surgery right after the first surgical incision. | Drug | Tranexamic acid single dose of 500mg |
| saline solution5cc saline solution | Drug | Saline |
Primary outcome
Duration of DCR surgery in minutes and amount of blood loss in milliliters during surgery.
Time frame: Blood loss will be measured at the end of DCR operation from the suction bowel. Duration of surgery will be caculated by registering time of operation start and end.
1 secondary outcome
Late onset postoperative epistaxis or periorbital hematoma
Time frame: 8 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2010.
- Results publication: PubMed 20063079Ralley FE, Berta D, Binns V, Howard J, Naudie DD. One intraoperative dose of tranexamic Acid for patients having primary hip or knee arthroplasty. Clin Orthop Relat Res. 2010 Jul;468(7):1905-11. doi: 10.1007/s11999-009-1217-8. Epub 2010 Jan 9.
- Results publication: PubMed 12825966Wellington K, Wagstaff AJ. Tranexamic acid: a review of its use in the management of menorrhagia. Drugs. 2003;63(13):1417-33. doi: 10.2165/00003495-200363130-00008.
- Results publication: PubMed 3321402Astedt B. Clinical pharmacology of tranexamic acid. Scand J Gastroenterol Suppl. 1987;137:22-5.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tranexamic acid and saline solution in people with Nasolacrimal Tract Obstruction, run by HaEmek Medical Center, Israel at 1 site in Israel.
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 3 inclusion and 7 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 15 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Haneen Jabaly-Habib, M.D. (972-506268059, hjabaly@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of DCR surgery in minutes and amount of blood loss in milliliters during surgery. (time frame: Blood loss will be measured at the end of DCR operation from the suction bowel. Duration of surgery will be caculated by registering time of operation start and end.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01221909, which also lists 3 linked publications.
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 15 Oct 2010.