A Phase 4 interventional study of Tranexamic acid and saline in Craniosynostosis and Bleeding, sponsored by University of Pittsburgh. Terminated at 1 site in United States. Open to participants aged 6 Months to 18 Years. Per ClinicalTrials.gov, last updated 2017-02-15.
Sponsored by University of Pittsburgh · Phase 4, Interventional, and Treatment
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.
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.
51 studies on the registry are indexed under Craniosynostoses; 14 are open to participants now.
This study's enrollment of 20 is below the median of 27 across 22 interventional studies indexed under Craniosynostoses.
Browse Craniosynostoses studies →University of Pittsburgh is the lead sponsor of 1,419 studies on the registry; 168 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
The inclusion of the patients will depend on the following criteria:
Exclusion Criteria:
Patients that will be excluded from the study include the following:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Tranexamic acid (100 mg/kg load, 10 mg/kg/hr) intravenous
Drug: Tranexamic acid
Saline was administered intravenously
Drug: saline
100 mg/kg load, then 10 mg/kg/hr
Placebo
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.
Time frame: intraoperative and postoperative (24 hr)
Number of Patients That Remained Transfusion Free
Time frame: 24 hours
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
| Milestone | Tranexamic Acid | Placebo |
|---|---|---|
| Started | 9 | 11 |
| Completed | 9 | 11 |
| Not completed | 0 | 0 |
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.
| ml/kg | Tranexamic Acid | Placebo |
|---|---|---|
| Total Volume (ml/kg) of Allogeneic Blood Exposure. | 16.1 ± 13.9 | 17.1 ± 10.4 |
| participants | Tranexamic Acid | Placebo |
|---|---|---|
| Number of Patients That Remained Transfusion Free | 2 | 0 |
| seconds | Tranexamic Acid | Placebo |
|---|---|---|
| PT -baseline | 15.1 ± 0.84 | 13.8 ± 0.74 |
| PT-after osteotomies | 18.5 ± 3.93 | 16.1 ± 1.94 |
| PT-immediately after surgery | 17.7 ± 1.18 | 17 ± 1.74 |
| PTT -baseline | 34.6 ± 2.92 | 32.9 ± 2.67 |
| PTT-after osteotomies | 37.2 ± 9.75 | 34.6 ± 3.62 |
| PTT-immediately after surgery | 33.3 ± 3.5 | 34.8 ± 3.9 |
| 10^9 platelets/L | Tranexamic Acid | Placebo |
|---|---|---|
| platelets-baseline | 301 ± 109 | 364 ± 125 |
| platelets-after osteotomies | 253 ± 101 | 300 ± 107 |
| platelets-immediately after surgery | 223 ± 89 | 231 ± 99 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tranexamic Acid | — | 0/9 (0%) | 0/9 (0%) |
| Placebo | — | 0/11 (0%) | 0/11 (0%) |
| Age, Categorical(Participants) | Tranexamic Acid | Placebo | Total |
|---|---|---|---|
| <=18 years | 9 | 11 | 20 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Tranexamic Acid | Placebo | Total |
|---|---|---|---|
| Female | 3 | 5 | 8 |
| Male | 6 | 6 | 12 |
Plan to share: 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.
The record gives a start of Jul 2008, a primary completion of Jun 2012 and a completion of Jun 2012. It does not say whether these dates are actual or estimated.
Results were first posted in Feb 2017, 4 years 8 months after primary completion.
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This study is terminated, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tranexamic Acid