Spinal Deformity, Paediatric Surgery, Tranexamic AcidEarly Phase 1NCT02093988
Topical Tranexamic Acid in Major Paediatric Spine Deformity Surgery: A Randomized Controlled Trial
A Early Phase 1 study testing Topical TXA and Intravenous TXA in people with Spinal Deformity, Paediatric Surgery, Tranexamic Acid, run by University of British Columbia at 1 site in Canada.
Trial summary
Our study will evaluate the use of topical and intravenous (IV) Tranexamic Acid (TXA) in spine surgery. The purpose of TXA is to prevent clotting during surgery to reduce blood loss. Read more about this study
- Who is it for?
- Ages 8 to 21 years
- Conditions the study is for
- Spinal Deformity, Paediatric Surgery, Tranexamic Acid
- What is being tested?
- Topical TXA and Intravenous TXA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2015to Feb 2017
- Phase
- Early Phase 1
- 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 8 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All participants between ages of 8 and 21 years old
- All patients undergoing spinal deformity surgery for which operative time is anticipated to be greater than 3 hours - Operative time will be defined as time from incision to closure
Who cannot join
- Violation of the dura intraoperatively
- Requirement of therapeutic anticoagulation in the perioperative period
- Baseline coagulation disorder
- History of thromboembolic event, including, but not limited to:
- Myocardial infarction within past 6 months
- Deep vein thrombosis
Show all 15Show fewer
- Pulmonary embolus
- Cerebrovascular accident or transient ischemic event
- Retinal artery occlusion
- Renal impairment - eGFR < 60 mL/min/1.73m2
- Pregnant
- Allergy to tranexamic acid
- Additional surgical procedures or interventions within the 7 days prior to the index spinal surgery, or within 72h following the index spinal surgery
- Planned staged procedures and procedures with less than 50 cc of blood loss not considered reason for study exclusion - Eg. change of negative pressure wound dressing, tracheostomy, central-line placement
- Inability of patient or legal guardian to provide study consent
Trial locations and contacts
1 site in 1 country.
Canada1 site
BC Children's Hospital
Vancouver, British Columbia, V6H 3V4
Sameer Desai, BSc, 6048752359, sameer.desai@cw.bc.ca
Chris Reilly, MD, FRCSC
About this study
Our study will evaluate the use of topical and intravenous (IV) Tranexamic Acid (TXA) in spine surgery. The purpose of TXA is to prevent clotting during surgery to reduce blood loss. When used intravenously, it has been shown to safe, efficacious, and effective in reducing transfusion requirements and blood loss in spine surgeries. We want to evaluate the effect of using TXA topically and intravenously to see if it further reduces blood loss in children undergoing major surgery compared to IV TXA only
Read the detailed description
Blood loss during major paediatric spine surgery is significant, and it is well established that patients undergoing such surgery have a substantial risk for requiring a blood transfusion in the perioperative period (1-4). Given the cost and associated risks with allogeneic blood product transfusion (5-7), a significant effort has been directed towards reducing transfusion requirements through various methods of blood conservation (8-12).
Tranexamic acid (TXA) is a synthetic antifibrinolytic that functions through competitive blockade of the lysine-binding sites of plasminogen, plasmin, and tissue plasminogen activator resulting in the inhibition of fibrinolysis and clot degradation (13). When used parentally, it has been shown to safe, efficacious, and effective in reducing transfusion requirements and blood loss during the perioperative period of various orthopaedic procedures, including major surgeries of the spine (14-23). A growing body of literature has supported the topical application of TXA in lower extremity joint reconstruction, among other procedures (24-29), in which a saline solution containing TXA is placed directly in the surgical incision prior to closure. Two randomized controlled trials have compared topical TXA and placebo for use in lumbar fusion and laminectomy cases. Both of these trials demonstrated a significant reduction in perioperative blood loss with the use of topical TXA as compared to placebo, and no reported no adverse events (36, 37).
While intravenous TXA has proven efficacy in reducing perioperative blood loss, despite its routine use during major paediatric spine surgery, blood loss and transfusion requirements remain significant (14-23). Thus, methods to further reduce perioperative blood loss in the children are of clinical significance. As highlighted above, topical TXA has clearly demonstrated excellent local anti-fibrinolytic action. Furthermore, when applied within a surgical incision, there is a negligible increase in serum TXA concentration (33-35).
We therefore propose a randomized trial to evaluate the effect of topical TXA on perioperative blood loss when used in addition to intravenous TXA for major paediatric spine surgery. In doing so, we seek to evaluate whether additional benefit may be conferred through direct application of TXA within the incision intravenous to that already provided by IV TXA. To date, such a question has not been evaluated in the surgical literature.
- Being tested
- Topical TXA, Intravenous TXA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical TXADrug
Also called TXA
Intravenous TXADrug
Also called TXA
| Study group | Role | What they receive |
|---|---|---|
| Topical and Intravenous TXA | Experimental | Not described Receives: Drug: Topical TXA; Drug: Intravenous TXA |
| Intravenous TXA only | Active comparator | Not described Receives: Drug: Intravenous TXA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume of Blood Loss
Measured: Intra-operative
Secondary outcomes (1)
Complications (reporting)
Any complications related to TXA administration will be recorded at the 6 week visit
Measured: 6 week visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2014 (estimated)
- Study startAug 2015
- Primary completionFeb 2017 (estimated)
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Deformity, Paediatric Surgery, Tranexamic AcidStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brett Kilb, Md, Study chair, ResidentFiroz Miyanji, MD, Principal investigator, Clinical Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02093988
- Sponsor's protocol ID
- H14-00595
- Status last verified
- Nov 2015
- First submitted
- 18 Mar 2014
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Tranexamic Acid in Major Paediatric Spine Deformity Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02093988
- Acronym / sponsor ID
- H14-00595
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 21 Mar 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.
Our study will evaluate the use of topical and intravenous (IV) Tranexamic Acid (TXA) in spine surgery. The purpose of TXA is to prevent clotting during surgery to reduce blood loss. When used intravenously, it has been shown to safe, efficacious, and effective in reducing transfusion requirements and blood loss in spine surgeries. We want to evaluate the effect of using TXA topically and intravenously to see if it further reduces blood loss in children undergoing major surgery compared to IV TXA only
Detailed description
Blood loss during major paediatric spine surgery is significant, and it is well established that patients undergoing such surgery have a substantial risk for requiring a blood transfusion in the perioperative period (1-4). Given the cost and associated risks with allogeneic blood product transfusion (5-7), a significant effort has been directed towards reducing transfusion requirements through various methods of blood conservation (8-12).
Tranexamic acid (TXA) is a synthetic antifibrinolytic that functions through competitive blockade of the lysine-binding sites of plasminogen, plasmin, and tissue plasminogen activator resulting in the inhibition of fibrinolysis and clot degradation (13). When used parentally, it has been shown to safe, efficacious, and effective in reducing transfusion requirements and blood loss during the perioperative period of various orthopaedic procedures, including major surgeries of the spine (14-23). A growing body of literature has supported the topical application of TXA in lower extremity joint reconstruction, among other procedures (24-29), in which a saline solution containing TXA is placed directly in the surgical incision prior to closure. Two randomized controlled trials have compared topical TXA and placebo for use in lumbar fusion and laminectomy cases. Both of these trials demonstrated a significant reduction in perioperative blood loss with the use of topical TXA as compared to placebo, and no reported no adverse events (36, 37).
While intravenous TXA has proven efficacy in reducing perioperative blood loss, despite its routine use during major paediatric spine surgery, blood loss and transfusion requirements remain significant (14-23). Thus, methods to further reduce perioperative blood loss in the children are of clinical significance. As highlighted above, topical TXA has clearly demonstrated excellent local anti-fibrinolytic action. Furthermore, when applied within a surgical incision, there is a negligible increase in serum TXA concentration (33-35).
We therefore propose a randomized trial to evaluate the effect of topical TXA on perioperative blood loss when used in addition to intravenous TXA for major paediatric spine surgery. In doing so, we seek to evaluate whether additional benefit may be conferred through direct application of TXA within the incision intravenous to that already provided by IV TXA. To date, such a question has not been evaluated in the surgical literature.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical and Intravenous TXA | Experimental | Drug: Topical TXA, Drug: Intravenous TXA |
| Intravenous TXA only | Active comparator | Drug: Intravenous TXA |
Who may qualify
- Ages
- 8 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- All participants between ages of 8 and 21 years old
- All patients undergoing spinal deformity surgery for which operative time is anticipated to be greater than 3 hours - Operative time will be defined as time from incision to closure
Key exclusion criteria (15 listed)
- Violation of the dura intraoperatively
- Requirement of therapeutic anticoagulation in the perioperative period
- Baseline coagulation disorder
- History of thromboembolic event, including, but not limited to:
- Myocardial infarction within past 6 months
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 |
|---|---|---|
| Topical TXAAlso: TXA | Drug | Topical and Intravenous TXA |
| Intravenous TXAAlso: TXA | Drug | Intravenous TXA only, Topical and Intravenous TXA |
Primary outcome
Volume of Blood Loss
Time frame: Intra-operative
1 secondary outcome
Complications (reporting)
Time frame: 6 week visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
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.
Brett Kilb, Md study chair
Resident
Firoz Miyanji, MD principal investigator
Clinical Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Topical TXA and Intravenous TXA in people with Spinal Deformity, Paediatric Surgery, Tranexamic Acid, run by University of British Columbia 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 2 inclusion and 15 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 2 Dec 2015. 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume of Blood Loss (time frame: Intra-operative). 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 2 Dec 2015.