Tranexamic Acid for Craniofacial Surgery
Recruitment status was Recruiting
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Purpose
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 |
|---|---|---|
|
Cranial Vault Surgery for Craniosynostosis |
Drug: Tranexamic acid Drug: saline |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Tranexamic Acid for the Reduction of Allogeneic Blood Exposure in Infants and Children Having Craniofacial Surgery |
- Total volume (ml/kg) of allogeneic blood exposure [ Time Frame: intraoperative and postoperative (24 hr) ] [ Designated as safety issue: No ]
- Effect of tranexamic acid on PT,PTT, PLT, fibrinogen, and TEG [ Time Frame: 24 hr ] [ Designated as safety issue: No ]
- Thromboembolic events [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
| 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 |
|---|---|
|
Experimental: 1
Tranexamic acid (100 mg/kg load, 10 mg/kg/hr)
|
Drug: Tranexamic acid
100 mg/kg load, then 10 mg/kg/hr
|
|
Placebo Comparator: 2
Saline
|
Drug: saline
Placebo
|
Eligibility| 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:
- 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 Criteria:
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
Contacts and Locations| 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 | |
More Information
Publications:
| Responsible Party: | Franklyn P Cladis MD, Assistant Professor of Anesthesiology, University of Pittsburgh, UPMC |
| ClinicalTrials.gov Identifier: | NCT00722436 History of Changes |
| Other Study ID Numbers: | PRO07120134 |
| Study First Received: | July 23, 2008 |
| Last Updated: | July 24, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Pittsburgh:
|
craniosynostosis antifibrinolytics transfusion tranexamic acid |
Additional relevant MeSH terms:
|
Craniosynostoses Synostosis Dysostoses Bone Diseases, Developmental Bone Diseases Musculoskeletal Diseases Craniofacial Abnormalities Musculoskeletal Abnormalities Plagiocephaly Congenital Abnormalities |
Tranexamic Acid Antifibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Hemostatics Coagulants Hematologic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013