Non-idiopathic ScoliosisPhase 2NCT01089140
Non-Idiopathic Scoliosis Treated With Tranexamic Acid
A Phase 2 study testing Tranexamic acid 10mg/kg/hr, Tranexamic acid 100 mg/kg/h infusion and Saline solution in people with Non-idiopathic Scoliosis, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
Investigation of tranexamic acid (TXA) for reducing perioperative blood loss and transfusion requirement in pediatric patients with secondary scoliosis undergoing posterior spinal fusion. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Non-idiopathic Scoliosis
- What is being tested?
- Tranexamic acid 10mg/kg/hr, Tranexamic acid 100 mg/kg/h infusion and Saline solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2014to Nov 2014
- Phase
- Phase 2
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1. Children with secondary scoliosis undergoing posterior spinal fusion
Who cannot join
- Known bleeding disorder as this may increase the risk of bleeding
- Current antifibrinolytic therapy as these patients may bleed less
- Patient or family history of thromboembolic disease as there may be potential risk of thrombosis
- Use of NSAIDS within 5 days of surgery as this may increase the risk of bleeding
- Known allergy to TXA
- History of renal insufficiency as TXA is renally excreted
- Colour vision disturbance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Blood Loss and Transfusion Requirement in Pediatric Patients With Non-Idiopathic Scoliosis Treated With Tranexamic Acid Undergoing Posterior Spinal Instrumentation and Fusion.
Investigation of tranexamic acid (TXA) for reducing perioperative blood loss and transfusion requirement in pediatric patients with secondary scoliosis undergoing posterior spinal fusion.
Read the detailed description
To investigate whether tranexamic acid (TXA) reduces perioperative blood loss and transfusion requirement in pediatric patients with secondary scoliosis undergoing posterior spinal fusion.In addition determination of the optimal TXA dosing for perioperative reduction of blood loss and transfusion requirement as well as to evaluate use of thromboelastography (TEG) as a measure of coagulation and fibrinolysis in pediatric patients with secondary scoliosis undergoing posterior spinal fusion (this may help guide blood product therapy).
The investigation will determine the effects of TXA on the TEG profile and whether plasminogen activator inhibitor-1 (PAI-1) level affects bleeding and transfusion requirement during scoliosis surgery. Finally to investigate whether PAI-1 level affects bleeding in response to TXA during scoliosis surgery.
- Conditions
- Non-idiopathic Scoliosis
- Being tested
- Tranexamic acid 10mg/kg/hr, Tranexamic acid 100 mg/kg/h infusion, Saline solution
- Keywords
- pediatrics, scoliosis, tranexamic acid, Investigating non-idiopathic scoliosis
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acid 10mg/kg/hrDrug
Also called TXA
Tranexamic acid is a synthetic antifibrinolytic drug that competitively inhibits the lysine binding sites of plasminogen, plasmin, and tissue plasminogen activator
Tranexamic acid 100 mg/kg/h infusionDrug
Also called TXA
Tranexamic acid is a synthetic antifibrinolytic drug that competitively inhibits the lysine binding sites of plasminogen, plasmin, and tissue plasminogen activator.
Saline solutionDrug
Saline placebo
| Study group | Role | What they receive |
|---|---|---|
| . Tranexamic acid low dose 10 mg/kg | Experimental | Not described Receives: Drug: Tranexamic acid 10mg/kg/hr |
| Tranexamic acid 100mg/kg | Experimental | Not described Receives: Drug: Tranexamic acid 100 mg/kg/h infusion |
| Saline Placebo | 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.
Perioperative blood loss and transfusion requirement
Measured: 8 hours
Secondary outcomes (2)
Thromboelastography (TEG): TEG monitors coagulation of blood samples in vitro to produce a complete picture of clot formation, strength and dissolution (i.e. fibrinolysis).
Measured: After Induction- Prior to Drug Administration, Immediately after Bolus Dose
Plasminogen Activator Inhibitor-1
Different genotypes for the plasminogen activator inhibitor-1 (PAI-1) gene may have varying degrees of bleeding. PAI-1 inhibits the transformation of plasminogen to plasmin thereby decreasing plasmin-induced fibrinolysis. Thus, PAI-1 promotes clot stability.
Measured: Baseline -Immediately after induction and prior to administration of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2010 (estimated)
- Study startNov 2014
- Primary completionNov 2014
- Study completionNov 2014
Why it stopped: Inadequate number of potential participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tara Der, The Hospital for Sick Children
- Investigators
- Tara Der, M.sc. MD.,(FRCPC), Principal investigator, Hospital for SickkIds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01089140
- Sponsor's protocol ID
- 1000013524
- Status last verified
- Jul 2019
- First submitted
- 11 Mar 2010
- Last updated
- 15 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Loss and Transfusion Requirement in Pediatric Patients With Non-Idiopathic Scoliosis Treated With Tranexamic Acid Undergoing Posterior Spinal Instrumentation and Fusion.
- ClinicalTrials.gov ID
- NCT01089140
- Acronym / sponsor ID
- 1000013524
- Conditions
- Non-idiopathic Scoliosis
- Keywords
- pediatrics, scoliosis, tranexamic acid, Investigating non-idiopathic scoliosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inadequate number of potential participants
- Enrolment
- 2 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Nov 2014 (actual)
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 18 Mar 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.
Investigation of tranexamic acid (TXA) for reducing perioperative blood loss and transfusion requirement in pediatric patients with secondary scoliosis undergoing posterior spinal fusion.
Detailed description
To investigate whether tranexamic acid (TXA) reduces perioperative blood loss and transfusion requirement in pediatric patients with secondary scoliosis undergoing posterior spinal fusion.In addition determination of the optimal TXA dosing for perioperative reduction of blood loss and transfusion requirement as well as to evaluate use of thromboelastography (TEG) as a measure of coagulation and fibrinolysis in pediatric patients with secondary scoliosis undergoing posterior spinal fusion (this may help guide blood product therapy).
The investigation will determine the effects of TXA on the TEG profile and whether plasminogen activator inhibitor-1 (PAI-1) level affects bleeding and transfusion requirement during scoliosis surgery. Finally to investigate whether PAI-1 level affects bleeding in response to TXA during scoliosis surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| . Tranexamic acid low dose 10 mg/kg | Experimental | Drug: Tranexamic acid 10mg/kg/hr |
| Tranexamic acid 100mg/kg | Experimental | Drug: Tranexamic acid 100 mg/kg/h infusion |
| Saline Placebo | Placebo comparator | Drug: Saline solution |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 1. Children with secondary scoliosis undergoing posterior spinal fusion
Key exclusion criteria (7 listed)
- Known bleeding disorder as this may increase the risk of bleeding
- Current antifibrinolytic therapy as these patients may bleed less
- Patient or family history of thromboembolic disease as there may be potential risk of thrombosis
- Use of NSAIDS within 5 days of surgery as this may increase the risk of bleeding
- Known allergy to TXA
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 10mg/kg/hrAlso: TXATranexamic acid is a synthetic antifibrinolytic drug that competitively inhibits the lysine binding sites of plasminogen, plasmin, and tissue plasminogen activator | Drug | . Tranexamic acid low dose 10 mg/kg |
| Tranexamic acid 100 mg/kg/h infusionAlso: TXATranexamic acid is a synthetic antifibrinolytic drug that competitively inhibits the lysine binding sites of plasminogen, plasmin, and tissue plasminogen activator. | Drug | Tranexamic acid 100mg/kg |
| Saline solutionSaline placebo | Drug | Saline Placebo |
Primary outcome
Perioperative blood loss and transfusion requirement
Time frame: 8 hours
2 secondary outcomes
Thromboelastography (TEG): TEG monitors coagulation of blood samples in vitro to produce a complete picture of clot formation, strength and dissolution (i.e. fibrinolysis).
Time frame: After Induction- Prior to Drug Administration, Immediately after Bolus Dose
Plasminogen Activator Inhibitor-1
Time frame: Baseline -Immediately after induction and prior to administration of study drug
Results and safety
The study was stopped early (reason given: Inadequate number of potential participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2019.
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Functional Limitations, Body Structure and Function Impairments, and Quality of Life in Adults After Surgical Treatment of Adolescent Idiopathic Scoliosis
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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.
Tara Der, M.sc. MD.,(FRCPC) principal investigator
Hospital for SickkIds
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tranexamic acid 10mg/kg/hr, Tranexamic acid 100 mg/kg/h infusion and Saline solution in people with Non-idiopathic Scoliosis, run by The Hospital for Sick Children 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 1 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: stopped early, as of the sponsor's last update on 15 Jul 2019. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 stopped early (reason given: Inadequate number of potential participants). 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?
Perioperative blood loss and transfusion requirement (time frame: 8 hours). 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 15 Jul 2019.