CraniosynostosisPhase 4NCT00722436
Tranexamic Acid for Craniofacial Surgery
A Phase 4 study testing Tranexamic acid and saline in people with Craniosynostosis and Bleeding, run by University of Pittsburgh at 1 site in United States.
Trial summary
This is a randomized, blinded, prospective study that will investigate the potential benefit of tranexamic acid to reduce the intraoperative bleeding and blood transfusions in pediatric patients undergoing craniofacial surgeries. Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Craniosynostosis, Bleeding
- 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
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Jun 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 6 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- The inclusion of the patients will depend on the following criteria:
- All pediatric patients scheduled for primary or secondary repair of craniosynostosis with a frontal orbital advancement, or cranial vault reconstruction.
- Patients will be between the ages of 6 months and 18 years old.
- They will be > than 5 kg.
- All subjects being evaluated in the Craniofacial Clinic for primary or secondary repair of craniosynostosis will potentially be included in the study. Prior to inclusion in the study potential participants will be screened by history and laboratory data. The laboratory data will include a complete blood count, PT, PTT, type and cross, factor V leiden, anticardiolipin antibody, and lupus anticoagulant. The history will be obtained from the parents or current care takers. The medical records may be reviewed if there is a need for clarification.
Who cannot join
- Patients that will be excluded from the study include the following:
- Familial or personal coagulopathy risk-factor V leiden, anticardiolipin antibody, and lupus anticoagulant
- Abnormal PT, PTT, Platelet count. or closing time. All patients presenting for craniofacial surgery have preoperative blood work performed which includes a type and screen, HCT, PLT, PT, PTT, and closing time. Patients who have abnormalities detected in their coagulation profile proceed on to a complete hematologic evaluation that includes an evaluation for Von Willebrand's Disease.
- History of thrombotic episodes in the patient
- Renal failure or hepatic failure.
- Infants less than 5 kg
- Age < 6 months or > 18 years old
Trial locations and contacts
1 site in 1 country.
United States1 site
The Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Tranexamic Acid for the Reduction of Allogeneic Blood Exposure in Infants and Children Having Craniofacial Surgery
This is a randomized, blinded, prospective study that will investigate the potential benefit of tranexamic acid to reduce the intraoperative bleeding and blood transfusions in pediatric patients undergoing craniofacial surgeries.
Read the detailed description
Surgical procedures for the correction of craniofacial deformities result in unavoidable and significant blood loss in small children and infants. Patients may experience blood losses that exceed one to two blood volumes. In an effort to reduce our transfusion requirements, we have introduced tranexamic acid into our practice. However, the benefit of tranexamic acid in pediatric craniofacial surgery has not yet been reported. We hypothesize that the intraoperative use of tranexamic acid in pediatric patients presenting for craniofacial reconstructions will reduce blood loss and allogeneic transfusion requirements.
This is a randomized, blinded, prospective study that will investigate the potential benefit of tranexamic acid to reduce the intraoperative bleeding and blood transfusions in pediatric patients undergoing craniofacial surgeries. An initial dose of 100 mg/kg tranexamic acid (Cyclokapron 100mg/ml) or an equal volume of a placebo will be administered over 15 minutes after the induction of anesthesia and before the skin incision. A maintenance infusion of 10 mg/kg/hr of tranexamic acid or equal volume of a placebo will be started upon completion of the initial dose and will be continued until skin closure. The primary outcome will include the reduction in the total volume of allogeneic erythrocytes.
- Conditions
- Craniosynostosis, Bleeding
- Being tested
- Tranexamic acid, saline
- Keywords
- antifibrinolytic, tranexamic acid
- 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
100 mg/kg load, then 10 mg/kg/hr
salineDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic acid | Experimental | Tranexamic acid (100 mg/kg load, 10 mg/kg/hr) intravenous Receives: Drug: Tranexamic acid |
| Placebo | Placebo comparator | Saline was administered intravenously Receives: Drug: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Volume (ml/kg) of Allogeneic Blood Exposure.
This is the blood administered during surgery. The blood comes form the blood bank. It is not cell salvage blood. The volume was normalized by weight.
Measured: intraoperative and postoperative (24 hr)
Number of Patients That Remained Transfusion Free
Measured: 24 hours
Secondary outcomes (2)
Effect of Tranexamic Acid on Prothrombin Time (PT), Partial Thromboplastin Time (PTT) at Three Time Points (Baseline, After Osteotomies, and Immediately After Procedure).
Measured: (baseline, after osteotomies, and immediately after procedure)
Platelets
Measured: baseline, after osteotomies, immediately after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionJun 2012
- Study completionJun 2012
Why it stopped: Study dose changed based on recent publications
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CraniosynostosisStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Franklyn Cladis, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00722436
- Sponsor's protocol ID
- PRO07120134
- Status last verified
- Feb 2017
- First submitted
- 23 Jul 2008
- Last updated
- 15 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: We stopped the study early because emerging data came out that demonstrated benefit with significantly lower doses than our study. We were compelled to stop enrolling.
Publications
Neilipovitz DT, Murto K, Hall L, Barrowman NJ, Splinter WM. A randomized trial of tranexamic acid to reduce blood transfusion for scoliosis surgery. Anesth Analg. 2001 Jul;93(1):82-7. doi: 10.1097/00000539-200107000-00018.
PubMed 11429344Sethna NF, Zurakowski D, Brustowicz RM, Bacsik J, Sullivan LJ, Shapiro F. Tranexamic acid reduces intraoperative blood loss in pediatric patients undergoing scoliosis surgery. Anesthesiology. 2005 Apr;102(4):727-32. doi: 10.1097/00000542-200504000-00006.
PubMed 15791100Henry DA, Moxey AJ, Carless PA, O'Connell D, McClelland B, Henderson KM, Sly K, Laupacis A, Fergusson D. Anti-fibrinolytic use for minimising perioperative allogeneic blood transfusion. Cochrane Database Syst Rev. 2001;(1):CD001886. doi: 10.1002/14651858.CD001886.
PubMed 11279735
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tranexamic Acid for the Reduction of Allogeneic Blood Exposure in Infants and Children Having Craniofacial Surgery
- ClinicalTrials.gov ID
- NCT00722436
- Acronym / sponsor ID
- PRO07120134
- Conditions
- Craniosynostosis, Bleeding
- Keywords
- antifibrinolytic, tranexamic acid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study dose changed based on recent publications
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 25 Jul 2008 (estimated)
- Results
- Posted 15 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, blinded, prospective study that will investigate the potential benefit of tranexamic acid to reduce the intraoperative bleeding and blood transfusions in pediatric patients undergoing craniofacial surgeries.
Detailed description
Surgical procedures for the correction of craniofacial deformities result in unavoidable and significant blood loss in small children and infants. Patients may experience blood losses that exceed one to two blood volumes. In an effort to reduce our transfusion requirements, we have introduced tranexamic acid into our practice. However, the benefit of tranexamic acid in pediatric craniofacial surgery has not yet been reported. We hypothesize that the intraoperative use of tranexamic acid in pediatric patients presenting for craniofacial reconstructions will reduce blood loss and allogeneic transfusion requirements.
This is a randomized, blinded, prospective study that will investigate the potential benefit of tranexamic acid to reduce the intraoperative bleeding and blood transfusions in pediatric patients undergoing craniofacial surgeries. An initial dose of 100 mg/kg tranexamic acid (Cyclokapron 100mg/ml) or an equal volume of a placebo will be administered over 15 minutes after the induction of anesthesia and before the skin incision. A maintenance infusion of 10 mg/kg/hr of tranexamic acid or equal volume of a placebo will be started upon completion of the initial dose and will be continued until skin closure. The primary outcome will include the reduction in the total volume of allogeneic erythrocytes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid | Experimental | Drug: Tranexamic acidTranexamic acid (100 mg/kg load, 10 mg/kg/hr) intravenous |
| Placebo | Placebo comparator | Drug: salineSaline was administered intravenously |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- All pediatric patients scheduled for primary or secondary repair of craniosynostosis with a frontal orbital advancement, or cranial vault reconstruction.
- Patients will be between the ages of 6 months and 18 years old.
- They will be > than 5 kg.
- All subjects being evaluated in the Craniofacial Clinic for primary or secondary repair of craniosynostosis will potentially be included in the study. Prior to inclusion in the study potential participants will be screened by history and laboratory data. The laboratory data will include a complete blood count, PT, PTT, type and cross, factor V leiden, anticardiolipin antibody, and lupus anticoagulant. The history will be obtained from the parents or current care takers. The medical records may be reviewed if there is a need for clarification.
Key exclusion criteria (7 listed)
- Familial or personal coagulopathy risk-factor V leiden, anticardiolipin antibody, and lupus anticoagulant
- Abnormal PT, PTT, Platelet count. or closing time. All patients presenting for craniofacial surgery have preoperative blood work performed which includes a type and screen, HCT, PLT, PT, PTT, and closing time. Patients who have abnormalities detected in their coagulation profile proceed on to a complete hematologic evaluation that includes an evaluation for Von Willebrand's Disease.
- History of thrombotic episodes in the patient
- Renal failure or hepatic failure.
- Infants less than 5 kg
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 acid100 mg/kg load, then 10 mg/kg/hr | Drug | Tranexamic acid |
| salinePlacebo | Drug | Placebo |
Primary outcome
Total Volume (ml/kg) of Allogeneic Blood Exposure.
Time frame: intraoperative and postoperative (24 hr)
This is the blood administered during surgery. The blood comes form the blood bank. It is not cell salvage blood. The volume was normalized by weight.
Number of Patients That Remained Transfusion Free
Time frame: 24 hours
2 secondary outcomes
Effect of Tranexamic Acid on Prothrombin Time (PT), Partial Thromboplastin Time (PTT) at Three Time Points (Baseline, After Osteotomies, and Immediately After Procedure).
Time frame: (baseline, after osteotomies, and immediately after procedure)
Platelets
Time frame: baseline, after osteotomies, immediately after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11429344Neilipovitz DT, Murto K, Hall L, Barrowman NJ, Splinter WM. A randomized trial of tranexamic acid to reduce blood transfusion for scoliosis surgery. Anesth Analg. 2001 Jul;93(1):82-7. doi: 10.1097/00000539-200107000-00018.
- Background: PubMed 15791100Sethna NF, Zurakowski D, Brustowicz RM, Bacsik J, Sullivan LJ, Shapiro F. Tranexamic acid reduces intraoperative blood loss in pediatric patients undergoing scoliosis surgery. Anesthesiology. 2005 Apr;102(4):727-32. doi: 10.1097/00000542-200504000-00006.
- Background: PubMed 11279735Henry DA, Moxey AJ, Carless PA, O'Connell D, McClelland B, Henderson KM, Sly K, Laupacis A, Fergusson D. Anti-fibrinolytic use for minimising perioperative allogeneic blood transfusion. Cochrane Database Syst Rev. 2001;(1):CD001886. doi: 10.1002/14651858.CD001886.
- Individual participant dataSharing planned: No. We stopped the study early because emerging data came out that demonstrated benefit with significantly lower doses than our study. We were compelled to stop enrolling.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Craniosynostosis and Bleeding, run by University of Pittsburgh at 1 site in United States.
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: stopped early, as of the sponsor's last update on 15 Feb 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 United States. 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?
Yes. Results are posted in the registry (first posted 15 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Total Volume (ml/kg) of Allogeneic Blood Exposure. (time frame: intraoperative and postoperative (24 hr)). The study lists 2 primary outcomes in all. 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 NCT00722436, which also lists 3 linked publications.
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 Feb 2017.