Tranexamic Acid for Craniofacial Surgery - Full Text View

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 IV

Genetics Home Reference related topics:

Apert syndrome Baller-Gerold syndrome Beare-Stevenson cutis gyrata syndrome Crouzonodermoskeletal syndrome Crouzon syndrome Jackson-Weiss syndrome Muenke syndrome Pfeiffer syndrome

MedlinePlus related topics:

Blood Transfusion and Donation

Drug Information available for:

Sodium chloride Tranexamic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

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

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:

Total volume (ml/kg) of allogeneic blood exposure [ Time Frame: intraoperative and postoperative (24 hr) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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
1: Experimental Tranexamic acid (100 mg/kg load, 10 mg/kg/hr)	Drug: Tranexamic acid 100 mg/kg load, then 10 mg/kg/hr
2: Placebo Comparator Saline	Drug: saline Placebo

Eligibility

Ages Eligible for Study:	6 Months to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

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

Contacts


Contact: Franklyn P Cladis, MD	412-692-5260	cladf@upmc.edu

Locations


United States, Pennsylvania
	The Children's Hospital of Pittsburgh	Recruiting
	Pittsburgh, Pennsylvania, United States, 15213
	Contact: Franklyn Cladis, MD 412-692-5260

Sponsors and Collaborators

University of Pittsburgh

More Information

Publications:

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.

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.

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.

Responsible Party:	University of Pittsburgh, UPMC ( Franklyn P Cladis MD, Assistant Professor of Anesthesiology )
Study ID Numbers:	PRO07120134
First Received:	July 23, 2008
Last Updated:	July 24, 2008
ClinicalTrials.gov Identifier:	NCT00722436
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pittsburgh:

craniosynostosis antifibrinolytics transfusion tranexamic acid

Study placed in the following topic categories:

Craniosynostoses

Antiplasmin

Musculoskeletal Diseases

Craniofacial Abnormalities

Bone Diseases, Developmental

Tranexamic Acid

Craniosynostosis

Congenital Abnormalities

Bone Diseases

Musculoskeletal Abnormalities

Additional relevant MeSH terms:

Fibrin Modulating Agents

Antifibrinolytic Agents

Coagulants

Molecular Mechanisms of Pharmacological Action

Synostosis

Therapeutic Uses

Hematologic Agents

Dysostoses

Hemostatics

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 24, 2008

Sponsored by:	University of Pittsburgh
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00722436