Bleeding Clinical Trial
Official title:
Tranexamic Acid for the Reduction of Allogeneic Blood Exposure in Infants and Children Having Craniofacial Surgery
Verified date | February 2017 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 20 |
Est. completion date | June 2012 |
Est. primary completion date | June 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months to 18 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | The Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh |
United States,
Henry DA, Moxey AJ, Carless PA, O'Connell D, McClelland B, Henderson KM, Sly K, Laupacis A, Fergusson D. Anti-fibrinolytic use for minimising perioperative allogeneic blood transfusion. Cochrane Database Syst Rev. 2001;(1):CD001886. Review. Update in: Cochrane Database Syst Rev. 2007;(4):CD001886. — View Citation
Neilipovitz DT, Murto K, Hall L, Barrowman NJ, Splinter WM. A randomized trial of tranexamic acid to reduce blood transfusion for scoliosis surgery. Anesth Analg. 2001 Jul;93(1):82-7. — View Citation
Sethna NF, Zurakowski D, Brustowicz RM, Bacsik J, Sullivan LJ, Shapiro F. Tranexamic acid reduces intraoperative blood loss in pediatric patients undergoing scoliosis surgery. Anesthesiology. 2005 Apr;102(4):727-32. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total Volume (ml/kg) of Allogeneic Blood Exposure. | This is the blood administered during surgery. The blood comes form the blood bank. It is not cell salvage blood. The volume was normalized by weight. | intraoperative and postoperative (24 hr) | |
Primary | Number of Patients That Remained Transfusion Free | 24 hours | ||
Secondary | Effect of Tranexamic Acid on Prothrombin Time (PT), Partial Thromboplastin Time (PTT) at Three Time Points (Baseline, After Osteotomies, and Immediately After Procedure). | (baseline, after osteotomies, and immediately after procedure) | ||
Secondary | Platelets | baseline, after osteotomies, immediately after surgery |
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