Tranexamic Acid for Craniofacial Surgery

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Craniosynostosis, Bleeding

In brief

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.

Key facts

Study ID

NCT00722436

Run by

University of Pittsburgh

People needed

20

Starts

2008-07-01

Expected to finish

2012-06-01

Last updated by the study team

2017-02-15

Who can join

Age: 1 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• The Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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