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Tranexamic Acid for Craniofacial Surgery

This study has been terminated.
(Study dose changed based on recent publications)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00722436
First Posted: July 25, 2008
Last Update Posted: February 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Franklyn Cladis, University of Pittsburgh
July 23, 2008
July 25, 2008
September 16, 2016
February 15, 2017
February 15, 2017
July 2008
June 2012   (Final data collection date for primary outcome measure)
  • Total Volume (ml/kg) of Allogeneic Blood Exposure. [ Time Frame: intraoperative and postoperative (24 hr) ]
    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.
  • Number of Patients That Remained Transfusion Free [ Time Frame: 24 hours ]
Total volume (ml/kg) of allogeneic blood exposure [ Time Frame: intraoperative and postoperative (24 hr) ]
Complete list of historical versions of study NCT00722436 on ClinicalTrials.gov Archive Site
  • Effect of Tranexamic Acid on Prothrombin Time (PT), Partial Thromboplastin Time (PTT) at Three Time Points (Baseline, After Osteotomies, and Immediately After Procedure). [ Time Frame: (baseline, after osteotomies, and immediately after procedure) ]
  • Platelets [ Time Frame: baseline, after osteotomies, immediately after surgery ]
  • Effect of tranexamic acid on PT,PTT, PLT, fibrinogen, and TEG [ Time Frame: 24 hr ]
  • Thromboembolic events [ Time Frame: 24 hours ]
Not Provided
Not Provided
 
Tranexamic Acid for Craniofacial Surgery
Tranexamic Acid for the Reduction of Allogeneic Blood Exposure in Infants and Children Having Craniofacial Surgery
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.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
  • Craniosynostosis
  • Bleeding
  • Drug: Tranexamic acid
    100 mg/kg load, then 10 mg/kg/hr
  • Drug: saline
    Placebo
  • Experimental: Tranexamic acid
    Tranexamic acid (100 mg/kg load, 10 mg/kg/hr) intravenous
    Intervention: Drug: Tranexamic acid
  • Placebo Comparator: Placebo
    Saline was administered intravenously
    Intervention: Drug: saline

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
20
June 2012
June 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
6 Months to 18 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00722436
PRO07120134
No
Not Provided
Plan to Share IPD: No
Plan Description: We stopped the study early because emerging data came out that demonstrated benefit with significantly lower doses than our study. We were compelled to stop enrolling.
Franklyn Cladis, University of Pittsburgh
University of Pittsburgh
Not Provided
Not Provided
University of Pittsburgh
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP