Tranexamic AcidPhase 4TXA-OMFSNCT03433144
The Effects of Tranexamic Acid on Blood Loss During Orthognathic Surgery
A Phase 4 study testing Tranexamic Acid Injectable Solution in people with Tranexamic Acid and Orthognathic Surgery, run by Nick Emanuele at 1 site in Canada.
Trial summary
This study seeks to answer the question: Does a single pre-operative dose of tranexamic acid have a statistically significant reduction in blood loss during orthognathic surgery? If it does, this drug may begin to be used routinely during orthognathic surgery to reduce blood loss in our patients. Read more about this study
- Who is it for?
- Ages 16 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tranexamic Acid, Orthognathic Surgery
- What is being tested?
- Tranexamic Acid Injectable Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2018to 6 Jul 2020
- Phase
- Phase 4
- 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 16 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing either
- Bilateral saggital split osteotomy (lower jaw surgery)
- Lefort 1 osteotomy (upper jaw surgery)
- Combination of BSSO and Lefort
- Patients between with ages of 16-65
- No cardiac comorbidities (hypertension, congenital heart malformation)
Show all 9Show fewer
- No known coagulopathy
- No regular prescription medication altering normal blood coagulation (NSAIDs, other anticoagulants)
- ASA I and II patients
Who cannot join
- Patients younger than 16 and older than 40
- Patients with known coagulopathy
- Patients with cardiac comorbidities
- Patients with a family history of bleeding disorders
- Patients who have undergone previous orthognathic surgery
- ASA III patients or higher
Trial locations and contacts
1 site in 1 country.
About this study
This study seeks to answer the question: Does a single pre-operative dose of tranexamic acid have a statistically significant reduction in blood loss during orthognathic surgery?
If it does, this drug may begin to be used routinely during orthognathic surgery to reduce blood loss in our patients.
- Conditions
- Tranexamic Acid, Orthognathic Surgery
- Being tested
- Tranexamic Acid Injectable Solution, Placebo (normal saline 0.9%)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic Acid Injectable SolutionDrug
the drug will be given to patients intravenously at a dose of 10mg/kg pre-operatively after induction on general anesthesia
Placebo (normal saline 0.9%)Other
An equivalent amount of normal saline (0.9%) will be given to the patient pre-operatively after induction of general anesthesia. The amount of saline given will correspond to the same amount of fluid which would have been given had the patient been in the intervention group.
| Study group | Role | What they receive |
|---|---|---|
| Intervention TXA | Experimental | patients receiving TXA10mg/kg IV pre-operatively Receives: Drug: Tranexamic Acid Injectable Solution |
| Placebo | Placebo comparator | patients will receive an equivalent amount of normal saline 0.9% IV pre-operatively Receives: Other: Placebo (normal saline 0.9%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood loss during surgery
meticulous measurement of the total blood loss encountered during surgery
Measured: intra-operative only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2018
- Study start1 Jun 2018
- Primary completion1 Feb 2019
- Study completion6 Jul 2020
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tranexamic AcidStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In this study, patients will be randomized into two groups: and intervention group and placebo. The intervention group will receive a single pre-operative dose of TXA IV (10mg/kg) and the placebo group will receive the same volume of fluid intravenously.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nick Emanuele
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nick Emanuele, Nova Scotia Health Authority
- Investigators
- Nick Emanuele, DDS, BBA, Principal investigator, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03433144
- Sponsor's protocol ID
- 1023246
- Acronym
- TXA-OMFS
- Status last verified
- Aug 2021
- First submitted
- 8 Feb 2018
- Last updated
- 6 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be used for internal use only
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Tranexamic Acid on Blood Loss During Orthognathic Surgery
- ClinicalTrials.gov ID
- NCT03433144
- Acronym / sponsor ID
- TXA-OMFS / 1023246
- Conditions
- Tranexamic Acid, Orthognathic Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nick EmanueleUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 6 Jul 2020 (actual)
- First posted
- 14 Feb 2018 (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.
This study seeks to answer the question: Does a single pre-operative dose of tranexamic acid have a statistically significant reduction in blood loss during orthognathic surgery?
If it does, this drug may begin to be used routinely during orthognathic surgery to reduce blood loss in our patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- In this study, patients will be randomized into two groups: and intervention group and placebo. The intervention group will receive a single pre-operative dose of TXA IV (10mg/kg) and the placebo group will receive the same volume of fluid intravenously.
| Arm | Type | Receives |
|---|---|---|
| Intervention TXA | Experimental | Drug: Tranexamic Acid Injectable Solutionpatients receiving TXA10mg/kg IV pre-operatively |
| Placebo | Placebo comparator | Other: Placebo (normal saline 0.9%)patients will receive an equivalent amount of normal saline 0.9% IV pre-operatively |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Patients undergoing either
- Patients between with ages of 16-65
- No cardiac comorbidities (hypertension, congenital heart malformation)
- No known coagulopathy
- No regular prescription medication altering normal blood coagulation (NSAIDs, other anticoagulants)
Key exclusion criteria (6 listed)
- Patients younger than 16 and older than 40
- Patients with known coagulopathy
- Patients with cardiac comorbidities
- Patients with a family history of bleeding disorders
- Patients who have undergone previous orthognathic surgery
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 Acid Injectable Solutionthe drug will be given to patients intravenously at a dose of 10mg/kg pre-operatively after induction on general anesthesia | Drug | Intervention TXA |
| Placebo (normal saline 0.9%)An equivalent amount of normal saline (0.9%) will be given to the patient pre-operatively after induction of general anesthesia. The amount of saline given will correspond to the same amount of fluid which would have been given had the patient been in the intervention group. | Other | Placebo |
Primary outcome
blood loss during surgery
Time frame: intra-operative only
meticulous measurement of the total blood loss encountered during surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2021.
- Individual participant dataSharing planned: No. The data will be used for internal use only
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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.
Nick Emanuele, DDS, BBA principal investigator
Nova Scotia Health Authority
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tranexamic Acid Injectable Solution in people with Tranexamic Acid and Orthognathic Surgery, run by Nick Emanuele at 1 site in Canada.
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 9 inclusion and 6 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: withdrawn, as of the sponsor's last update on 6 Aug 2021. 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 Canada. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
blood loss during surgery (time frame: intra-operative only). 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 6 Aug 2021.