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Sponsored by: |
University of Pittsburgh |
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Information provided by: | University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT00722436 |
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.
Condition | Intervention | Phase |
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Cranial Vault Surgery for Craniosynostosis |
Drug: Tranexamic acid Drug: saline |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Tranexamic Acid for the Reduction of Allogeneic Blood Exposure in Infants and Children Having Craniofacial Surgery |
Estimated Enrollment: | 20 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Tranexamic acid (100 mg/kg load, 10 mg/kg/hr)
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Drug: Tranexamic acid
100 mg/kg load, then 10 mg/kg/hr
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2: Placebo Comparator
Saline
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Drug: saline
Placebo
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Ages Eligible for Study: | 6 Months to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The inclusion of the patients will depend on the following criteria:
Exclusion Criteria:
Patients that will be excluded from the study include the following:
Contact: Franklyn P Cladis, MD | 412-692-5260 | cladf@upmc.edu |
United States, Pennsylvania | |
The Children's Hospital of Pittsburgh | Recruiting |
Pittsburgh, Pennsylvania, United States, 15213 | |
Contact: Franklyn Cladis, MD 412-692-5260 |
Responsible Party: | University of Pittsburgh, UPMC ( Franklyn P Cladis MD, Assistant Professor of Anesthesiology ) |
Study ID Numbers: | PRO07120134 |
Study First Received: | July 23, 2008 |
Last Updated: | July 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00722436 History of Changes |
Health Authority: | United States: Institutional Review Board |
craniosynostosis antifibrinolytics transfusion tranexamic acid |
Craniofacial Abnormalities Tranexamic Acid Bone Diseases Hemostatics Musculoskeletal Abnormalities Craniosynostoses Antiplasmin |
Fibrin Modulating Agents Antifibrinolytic Agents Musculoskeletal Diseases Bone Diseases, Developmental Congenital Abnormalities Craniosynostosis |
Coagulants Molecular Mechanisms of Pharmacological Action Craniofacial Abnormalities Hematologic Agents Tranexamic Acid Bone Diseases Hemostatics Pharmacologic Actions Musculoskeletal Abnormalities |
Craniosynostoses Fibrin Modulating Agents Antifibrinolytic Agents Synostosis Musculoskeletal Diseases Therapeutic Uses Bone Diseases, Developmental Dysostoses Congenital Abnormalities |