CraniosynostosesPhase 3NCT01094977
Blood Loss and Transfusion Requirement in Infants Treated With Tranexamic Acid
A Phase 3 study testing Tranexamic Acid in people with Craniosynostoses, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
The primary objective of this study is to investigate whether tranexamic acid (TXA) reduces perioperative blood loss and transfusion requirement in infants undergoing craniosynostosis surgery. Read more about this study
- Who is it for?
- Ages 2 months to 2 years
- Conditions the study is for
- Craniosynostoses
- What is being tested?
- Tranexamic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2010to Jan 2020
- Phase
- Phase 3
- 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 2 months to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants aged 2 months to 2 years undergoing anterior cranial vault reconstruction
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
- Acquired colour vision defects as one of the first signs of long term TXA toxicity is colour vision disturbance.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Blood Loss and Transfusion Requirement in Infants Treated With Tranexamic Acid Undergoing Craniosynostosis Reconstruction: A Randomized Placebo-Controlled Double Blind Study of Low and High Dose Therapy
The primary objective of this study is to investigate whether tranexamic acid (TXA) reduces perioperative blood loss and transfusion requirement in infants undergoing craniosynostosis surgery.
Read the detailed description
Blood loss during pediatric craniosynostosis surgery can be significant and this may be exacerbated by a dilutional coagulopathy. Multimodal blood conservation strategies may limit allogeneic transfusions, although RCTs are few and limited. It is essential to investigate these techniques to determine their potential to reduce allogeneic blood transfusions and their associated cost and morbidity.
Tranexamic acid (TXA) is a synthetic antifibrinolytic drug that competitively inhibits the lysine binding sites of plasminogen, plasmin, and tissue plasminogen activator. The result is inhibition of fibrinolysis and clot degradation.
Recent studies in adults undergoing cardiac surgery demonstrated that people with 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 and the PAI-1 polymorphism will affect the degree of bleeding and response to TXA during craniosynostosis surgery.
- Conditions
- Craniosynostoses
- Being tested
- Tranexamic Acid, Saline Placebo
- Keywords
- Blood Loss and Transfusion, Craniosynostoses, Tranexamic Acid, Children
- Medical subject headings
- Craniosynostoses, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
10 mg/kg bolus with a 5 mg/kg/h infusion
Tranexamic AcidDrug
100 mg/kg bolus with a 10 mg/kg/h infusion
Saline PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Low Dose | Experimental | TXA 10mg/kg bolus before incision and 5 mg/kg infusion until skin closure Receives: Drug: Tranexamic Acid |
| High Dose | Experimental | TXA 100 mg/kg bolus before incision and 10 mg/kg infusion until skin closure Receives: Drug: Tranexamic Acid |
| Placebo | Placebo comparator | Normal saline 10 ml before skin incision and infusion according to weight until skin closure Receives: Drug: Saline Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Loss
Blood loss will be carefully measured in sponges, suction cannisters, cell saver systems, and in the plastic pockets of surgical drapes.
Measured: Prior and Post Surgery
Secondary outcomes (2)
Plasminogen Activator Inhibitor-1 (PAI-1) Polymorphism - Samples
PAI-1 promotes clot stability and the PAI-1 polymorphism will affect the degree of bleeding and response to TXA during craniosynostosis surgery
Measured: Sample will be drawn immediately after induction and prior to administration of study drug
Thromboelastography (TEG)Sample
TEG monitors coagulation of blood samples in vitro to produce a complete picture of clot formation, strength and dissolution (i.e. fibrinolysis)
Measured: Baseline, immediately after bolus dose of TXA is infused
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2010 (estimated)
- Study startJan 2010
- Primary completionJan 2020 (estimated)
- Study completionJan 2020 (estimated)
Why it stopped: Inadequate funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CraniosynostosesStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 90 participants (estimated)
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, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01094977
- Sponsor's protocol ID
- 1000013836
- Status last verified
- Jul 2019
- First submitted
- 23 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 Infants Treated With Tranexamic Acid Undergoing Craniosynostosis Reconstruction: A Randomized Placebo-Controlled Double Blind Study of Low and High Dose Therapy
- ClinicalTrials.gov ID
- NCT01094977
- Acronym / sponsor ID
- 1000013836
- Conditions
- Craniosynostoses
- Keywords
- Blood Loss and Transfusion, Craniosynostoses, Tranexamic Acid, Children
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Inadequate funding
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Jan 2010 (actual)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 29 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.
The primary objective of this study is to investigate whether tranexamic acid (TXA) reduces perioperative blood loss and transfusion requirement in infants undergoing craniosynostosis surgery.
Detailed description
Blood loss during pediatric craniosynostosis surgery can be significant and this may be exacerbated by a dilutional coagulopathy. Multimodal blood conservation strategies may limit allogeneic transfusions, although RCTs are few and limited. It is essential to investigate these techniques to determine their potential to reduce allogeneic blood transfusions and their associated cost and morbidity.
Tranexamic acid (TXA) is a synthetic antifibrinolytic drug that competitively inhibits the lysine binding sites of plasminogen, plasmin, and tissue plasminogen activator. The result is inhibition of fibrinolysis and clot degradation.
Recent studies in adults undergoing cardiac surgery demonstrated that people with 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 and the PAI-1 polymorphism will affect the degree of bleeding and response to TXA during craniosynostosis surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Dose | Experimental | Drug: Tranexamic AcidTXA 10mg/kg bolus before incision and 5 mg/kg infusion until skin closure |
| High Dose | Experimental | Drug: Tranexamic AcidTXA 100 mg/kg bolus before incision and 10 mg/kg infusion until skin closure |
| Placebo | Placebo comparator | Drug: Saline PlaceboNormal saline 10 ml before skin incision and infusion according to weight until skin closure |
Who may qualify
- Ages
- 2 months to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infants aged 2 months to 2 years undergoing anterior cranial vault reconstruction
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 Acid10 mg/kg bolus with a 5 mg/kg/h infusion | Drug | Low Dose |
| Tranexamic Acid100 mg/kg bolus with a 10 mg/kg/h infusion | Drug | High Dose |
| Saline Placebo | Drug | Placebo |
Primary outcome
Blood Loss
Time frame: Prior and Post Surgery
Blood loss will be carefully measured in sponges, suction cannisters, cell saver systems, and in the plastic pockets of surgical drapes.
2 secondary outcomes
Plasminogen Activator Inhibitor-1 (PAI-1) Polymorphism - Samples
Time frame: Sample will be drawn immediately after induction and prior to administration of study drug
Thromboelastography (TEG)Sample
Time frame: Baseline, immediately after bolus dose of TXA is infused
Results and safety
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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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, MD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tranexamic Acid in people with Craniosynostoses, 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: paused, 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
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 (time frame: Prior and Post Surgery). 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.