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Tranexamic Acid for Craniofacial Surgery

This study has been terminated.
(Study dose changed based on recent publications)
Sponsor:
Information provided by (Responsible Party):
Franklyn Cladis, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00722436
First received: July 23, 2008
Last updated: February 10, 2017
Last verified: February 2017
  Purpose
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.

Condition Intervention Phase
Craniosynostosis Bleeding Drug: Tranexamic acid Drug: saline Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Tranexamic Acid for the Reduction of Allogeneic Blood Exposure in Infants and Children Having Craniofacial Surgery

Resource links provided by NLM:


Further study details as provided by Franklyn Cladis, University of Pittsburgh:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 20
Study Start Date: July 2008
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tranexamic acid
Tranexamic acid (100 mg/kg load, 10 mg/kg/hr) intravenous
Drug: Tranexamic acid
100 mg/kg load, then 10 mg/kg/hr
Placebo Comparator: Placebo
Saline was administered intravenously
Drug: saline
Placebo

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 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.

  Eligibility

Ages Eligible for Study:   6 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00722436

Locations
United States, Pennsylvania
The Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
  More Information

Publications:
Responsible Party: Franklyn Cladis, Associate Professor of Anesthesiology, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00722436     History of Changes
Other Study ID Numbers: PRO07120134
Study First Received: July 23, 2008
Results First Received: September 16, 2016
Last Updated: February 10, 2017
Individual Participant Data (IPD) Sharing Statement:
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.

Keywords provided by Franklyn Cladis, University of Pittsburgh:
antifibrinolytic, tranexamic acid

Additional relevant MeSH terms:
Craniosynostoses
Synostosis
Dysostoses
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Congenital Abnormalities
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants

ClinicalTrials.gov processed this record on August 22, 2017