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临床试验/NCT00722436
NCT00722436终止4 期

Tranexamic Acid for the Reduction of Allogeneic Blood Exposure in Infants and Children Having Craniofacial Surgery

University of Pittsburgh1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2008年7月最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
终止
入组人数
20
试验地点
1
主要终点
Total Volume (ml/kg) of Allogeneic Blood Exposure.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
6 Months 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

研究组 & 干预措施

Tranexamic acid

Experimental

Tranexamic acid (100 mg/kg load, 10 mg/kg/hr) intravenous

干预措施: Tranexamic acid (Drug)

Placebo

Placebo Comparator

Saline was administered intravenously

干预措施: saline (Drug)

结局指标

主要结局

Total Volume (ml/kg) of Allogeneic Blood Exposure.

时间窗: 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

时间窗: 24 hours

次要结局

  • 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))
  • Platelets(baseline, after osteotomies, immediately after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Franklyn Cladis

Associate Professor of Anesthesiology

University of Pittsburgh

研究点 (1)

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