Intraoperative BleedingPhase 4TXA2014-15NCT02229292
Prevention of Intraoperative Bleeding and Postoperative Swelling in Orthognathic Surgery Through the Use of Tranexamic Acid
A Phase 4 study testing Tranexamic Acid and Saline in people with Intraoperative Bleeding and Postoperative Edema, run by Esbjerg Hospital - University Hospital of Southern Denmark at 1 site in Denmark.
Trial summary
Purpose of the study: To evaluate the effect of tranexamic acid (TXA) of intraoperative blood loss in patients subjected to bi-maxillary orthognathic surgery To evaluate the potential effect of TXA on fibrin structure To evaluate the potential effect of TXA of binding of plasminogen to fibrin To evaluate the potential… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intraoperative Bleeding, Postoperative Edema
- What is being tested?
- Tranexamic Acid and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteDenmark
- Study dates
- 19 Aug 2014to 26 Sep 2016
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients must be 18 years or older
- Patients must be eligible for elective bi-maxillary orthognathic surgery
- No severe reduction of kidney function
- No known medical conditions
- Signed informed consent
Who cannot join
- Hypersensitivity to tranexamic acid
- A medical history of acute venous thrombosis and/or arterial thrombosis
- The presence of fibrinolytic conditions as a result of disseminated intravascular coagulation, with the exception of a predominant activation of the fibrinolytic system with acute severe bleeding.
- Severe kidney deficiency
- Cramps in the medical history
- Intake of Omega-3 fatty acids, Gingko Biloba, ginger and garlic supplements within 3 months of surgery.
- Pregnancy (female participants will be tested on the day of surgery)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Bleeding and Edema in Bimaxillary Orthognathic Surgery; the Effectiveness of Tranexamic Acid on Intraoperative Bleeding and Postoperative Swelling in Orthognathic Surgery.
Purpose of the study:
- To evaluate the effect of tranexamic acid (TXA) of intraoperative blood loss in patients subjected to bi-maxillary orthognathic surgery
- To evaluate the potential effect of TXA on fibrin structure
- To evaluate the potential effect of TXA of binding of plasminogen to fibrin
- To evaluate the potential effect of TXA on postoperative edema formation.
Hypothesis:
H0: Intraoperative bleeding cannot be significantly reduced by preoperative administration of tranexamic acid
H0,1: Postoperative edema cannot be significantly reduced by preoperative administration of tranexamic acid
Read the detailed description
The study population consists of patients referred to simultaneous mandibular and maxillary osteotomy at the Department of Oral and Maxillofacial Surgery, Hospital of South West Denmark in 2014.
Hundred patients (50 men and 50 women) will be enrolled in the study. Reportedly, the mean intraoperative blood loss in the placebo group is expected to be 436 ml with a standard deviation of 208 ml. The difference in blood loss between the TXA-group and the placebo group to be detected is 100 ml. The dropout frequency is estimated to 10%. To fulfil these assumptions a minimum of 40 patients should be included in each group to reach a power of 0.8 and an alpha of 0.05. In order to accommodate an even gender distribution a block randomization is performed resulting in the randomization of 100 patients.
The patients will be randomized to receive blindly either 10 ml tranexamic acid (100 mg/ml) (Pfizer, Ballerup, Denmark) or 10 ml saline (9mg/ml) preoperatively. Intraoperative blood loss will be determined by deducting the total volume of irrigation fluids from the volume of the contents of the surgical suction device. Postoperative edema formation will be determined by 3D surface scanning and volumetric analysis will be carried out in the "Landmarker" software.
- Conditions
- Intraoperative Bleeding, Postoperative Edema
- Being tested
- Tranexamic Acid, Saline
- Medical subject headings
- Blood Loss, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
Also called Tranexamsyre "Pfizer", D.SP.NR.: 22646, ATC code: B 02 AA 02
Active group:
Undergoes elective bi-maxillary orthognathic surgery consisting of a (un)/segmented LeFort I osteotomy combined with a bilateral sagittal split osteotomy, under the influence of 10ml tranexamic acid (100mg/ml) administered iv. prior to the onset of the surgical procedure.
SalineDrug
Also called Natriumklorid "B. Braun", D.SP.NR.: 6856, ATC code: V 07 AB
Placebo group:
Undergoes elective bi-maxillary orthognathic surgery consisting of a (un)/segmented LeFort I osteotomy combined with a bilateral sagittal split osteotomy, under the influence of 10ml sodium chloride (9mg/ml) administered iv. prior to the onset of the surgical procedure.
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic acid | Active comparator | The active comparator consists of an intravenously administered bolus injection of 10ml of 100mg/ml tranexamic (1g in total) given as a single dose, after the onset of anesthesia, prior to surgery. Receives: Drug: Tranexamic Acid |
| Saline | Placebo comparator | The placebo consists of an intravenously administered bolus injection of 10 ml of 9mg/ml sodium chloride given as a single dose after the onset of anesthesia, prior to surgery. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-operative bleeding volume (ml)
Measured: Within 10 minutes after ended surgery
Secondary outcomes (3)
Change in hemostatic profile
Changes in the hemostatic profile measured through thrombelastography, thrombin generation test and fibrin structure analysis.
Measured: Baseline, 5.5 hours, 48 hours and 4 months postoperatively
Change in inflammatory profile
Changes in the inflammatory profile are investigated through measures of surface induced activation, inflammation and plasminogen binding.
Measured: Baseline, 5.5 hours, 48 hours and 4 months postoperatively
Postoperative edema formation
The degree of postoperative swelling in connection with TXA /or not, is determined by non-invasive 3D face scans and quantified using the "Landmarker" software. Scans are carried out along with the 3rd and 4th blood samples, 48 hours and 4 months postoperatively.
Measured: 48 hours and 4 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2014 (estimated)
- Study start19 Aug 2014
- Primary completion26 Sep 2016
- Study completion26 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intraoperative BleedingStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Esbjerg Hospital - University Hospital of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, Vestjydsk Ortopædisk Fond
- Responsible party
- Principal investigator, Jesper Jared Olsen, Esbjerg Hospital - University Hospital of Southern Denmark
- Investigators
- Jesper J Olsen, DDS, Principal investigator, Esbjerg Hospital - University Hospital of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02229292
- Sponsor's protocol ID
- 2013-005473-52
- Acronym
- TXA2014-15
- Status last verified
- Mar 2017
- First submitted
- 28 Aug 2014
- Last updated
- 10 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Song G, Yang P, Hu J, Zhu S, Li Y, Wang Q. The effect of tranexamic acid on blood loss in orthognathic surgery: a meta-analysis of randomized controlled trials. Oral Surg Oral Med Oral Pathol Oral Radiol. 2013 May;115(5):595-600. doi: 10.1016/j.oooo.2012.09.085. Epub 2012 Dec 20.
PubMed 23260768
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Bleeding and Edema in Bimaxillary Orthognathic Surgery; the Effectiveness of Tranexamic Acid on Intraoperative Bleeding and Postoperative Swelling in Orthognathic Surgery.
- ClinicalTrials.gov ID
- NCT02229292
- Acronym / sponsor ID
- TXA2014-15 / 2013-005473-52
- Conditions
- Intraoperative Bleeding, Postoperative Edema
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Esbjerg Hospital - University Hospital of Southern DenmarkUniversity, hospital or other
- Collaborators
- University of Copenhagen, Vestjydsk Ortopædisk Fond
- Study start
- 19 Aug 2014
- Primary completion
- 26 Sep 2016 (actual)
- Study completion
- 26 Sep 2016 (actual)
- First posted
- 1 Sep 2014 (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.
Purpose of the study:
- To evaluate the effect of tranexamic acid (TXA) of intraoperative blood loss in patients subjected to bi-maxillary orthognathic surgery
- To evaluate the potential effect of TXA on fibrin structure
- To evaluate the potential effect of TXA of binding of plasminogen to fibrin
- To evaluate the potential effect of TXA on postoperative edema formation.
Hypothesis:
H0: Intraoperative bleeding cannot be significantly reduced by preoperative administration of tranexamic acid
H0,1: Postoperative edema cannot be significantly reduced by preoperative administration of tranexamic acid
Detailed description
The study population consists of patients referred to simultaneous mandibular and maxillary osteotomy at the Department of Oral and Maxillofacial Surgery, Hospital of South West Denmark in 2014.
Hundred patients (50 men and 50 women) will be enrolled in the study. Reportedly, the mean intraoperative blood loss in the placebo group is expected to be 436 ml with a standard deviation of 208 ml. The difference in blood loss between the TXA-group and the placebo group to be detected is 100 ml. The dropout frequency is estimated to 10%. To fulfil these assumptions a minimum of 40 patients should be included in each group to reach a power of 0.8 and an alpha of 0.05. In order to accommodate an even gender distribution a block randomization is performed resulting in the randomization of 100 patients.
The patients will be randomized to receive blindly either 10 ml tranexamic acid (100 mg/ml) (Pfizer, Ballerup, Denmark) or 10 ml saline (9mg/ml) preoperatively. Intraoperative blood loss will be determined by deducting the total volume of irrigation fluids from the volume of the contents of the surgical suction device. Postoperative edema formation will be determined by 3D surface scanning and volumetric analysis will be carried out in the "Landmarker" software.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid | Active comparator | Drug: Tranexamic AcidThe active comparator consists of an intravenously administered bolus injection of 10ml of 100mg/ml tranexamic (1g in total) given as a single dose, after the onset of anesthesia, prior to surgery. |
| Saline | Placebo comparator | Drug: SalineThe placebo consists of an intravenously administered bolus injection of 10 ml of 9mg/ml sodium chloride given as a single dose after the onset of anesthesia, prior to surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients must be 18 years or older
- Patients must be eligible for elective bi-maxillary orthognathic surgery
- No severe reduction of kidney function
- No known medical conditions
- Signed informed consent
Key exclusion criteria (7 listed)
- Hypersensitivity to tranexamic acid
- A medical history of acute venous thrombosis and/or arterial thrombosis
- The presence of fibrinolytic conditions as a result of disseminated intravascular coagulation, with the exception of a predominant activation of the fibrinolytic system with acute severe bleeding.
- Severe kidney deficiency
- Cramps in the medical history
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 AcidAlso: Tranexamsyre "Pfizer", D.SP.NR.: 22646, ATC code: B 02 AA 02Active group: Undergoes elective bi-maxillary orthognathic surgery consisting of a (un)/segmented LeFort I osteotomy combined with a bilateral sagittal split osteotomy, under the influence of 10ml tranexamic acid (100mg/ml) administered iv. prior to the onset of the surgical procedure. | Drug | Tranexamic acid |
| SalineAlso: Natriumklorid "B. Braun", D.SP.NR.: 6856, ATC code: V 07 ABPlacebo group: Undergoes elective bi-maxillary orthognathic surgery consisting of a (un)/segmented LeFort I osteotomy combined with a bilateral sagittal split osteotomy, under the influence of 10ml sodium chloride (9mg/ml) administered iv. prior to the onset of the surgical procedure. | Drug | Saline |
Primary outcome
Intra-operative bleeding volume (ml)
Time frame: Within 10 minutes after ended surgery
3 secondary outcomes
Change in hemostatic profile
Time frame: Baseline, 5.5 hours, 48 hours and 4 months postoperatively
Change in inflammatory profile
Time frame: Baseline, 5.5 hours, 48 hours and 4 months postoperatively
Postoperative edema formation
Time frame: 48 hours and 4 months postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2017.
- Background: PubMed 23260768Song G, Yang P, Hu J, Zhu S, Li Y, Wang Q. The effect of tranexamic acid on blood loss in orthognathic surgery: a meta-analysis of randomized controlled trials. Oral Surg Oral Med Oral Pathol Oral Radiol. 2013 May;115(5):595-600. doi: 10.1016/j.oooo.2012.09.085. Epub 2012 Dec 20.
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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.
Jesper J Olsen, DDS principal investigator
Esbjerg Hospital - University Hospital of Southern Denmark
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 and Saline in people with Intraoperative Bleeding and Postoperative Edema, run by Esbjerg Hospital - University Hospital of Southern Denmark at 1 site in Denmark.
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 5 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: finished, as of the sponsor's last update on 10 Mar 2017. 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 Denmark. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Intra-operative bleeding volume (ml) (time frame: Within 10 minutes after ended surgery). 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 NCT02229292, which also lists 1 linked publication.
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 10 Mar 2017.