Tranexamic Acid for Craniofacial Surgery
| Status: | Completed |
|---|---|
| Conditions: | Other Indications |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | Any - 18 |
| Updated: | 5/27/2013 |
| Start Date: | July 2008 |
| End Date: | July 2010 |
| Contact: | Franklyn P Cladis, MD |
| Email: | cladf@upmc.edu |
| Phone: | 412-692-5260 |
Tranexamic Acid for the Reduction of Allogeneic Blood Exposure in Infants and Children Having Craniofacial Surgery
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, fresh frozen plasma, and
cryoprecipitate transfused in the peri operative period (intraoperative and postoperative)
and the number of patients that remain transfusion free. Secondary outcomes will include
changes in fibrinogen values, TEG, and clinical assessment of the surgical field.
Inclusion Criteria:
The inclusion of the patients will depend on the following criteria:
1. All pediatric patients scheduled for primary or secondary repair of craniosynostosis
with a frontal orbital advancement, or cranial vault reconstruction.
2. Patients will be between the ages of 6 months and 18 years old.
3. They will be > than 5 kg.
4. 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.
Exclusion Criteria:
Patients that will be excluded from the study include the following:
1. Familial or personal coagulopathy risk-factor V leiden, anticardiolipin antibody, and
lupus anticoagulant
2. 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.
3. History of thrombotic episodes in the patient
4. Renal failure or hepatic failure.
5. Infants less than 5 kg
6. Age < 6 months or > 18 years old
We found this trial at
1
site
4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
Pittsburgh, Pennsylvania 15224
412-692-5325
Children's Hospital of Pittsburgh of UPMC UPMC is one of the leading nonprofit health systems...
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