Status:
TERMINATED
Tranexamic Acid for Craniofacial Surgery
Lead Sponsor:
University of Pittsburgh
Conditions:
Craniosynostosis
Bleeding
Eligibility:
All Genders
6-18 years
Phase:
PHASE4
Brief 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 under...
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00722436
Start Date
July 1 2008
End Date
June 1 2012
Last Update
February 15 2017
Active Locations (1)
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1
The Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213