Effects of Tranexamic Acid on on Intra- and Postoperative bleeding, Blood transfusion and Coagulation in Children Undergoing Craniosynostosis Surgery

INTERVENTION: Trade Name: Tranexamic acid (tranexamsyre "Pfizer") Pharmaceutical Form: Concentrate and solvent for solution for injection/infusion INN or Proposed INN: tranexamic acid CAS Number: 1197‐18‐8 Other descriptive name: TRANEXAMIC ACID Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100‐ Pharmaceutical form of the placebo: Injection Route of administration of the placebo: Intravenous use CONDITION: Bleeding during paediatric Craniosynostosis surgery ; MedDRA version: 18.0 Level: PT Classification code 10049889 Term: Craniosynostosis System Organ Class: 10010331 ‐ Congenital, familial and genetic disorders Therapeutic area: Diseases [C] ‐ Musculoskeletal Diseases [C05] PRIMARY OUTCOME: Main Objective: To assess whether tranexamic acid can reduce peri ‐ and post operative bleeding in children undergoing surgery for craniosynostosis. Primary end point(s): Amount of blood lost during surgery; Amount of blood lost in the postoperative period (until 24 hours postoperative) Secondary Objective: To study the effect of tranexamic acid on coagulation and clot stability in children undergoing surgery for craniosynostosis Timepoint(s) of evaluation of this end point: Bloodloss is estimated at the end of operation and after 24 hours SECONDARY OUTCOME: Secondary end point(s): Hemoglobin ; Amount of fluids administered during surgery and until 24 hours postoperative ; Duration of surgery ; Blood clot stability Timepoint(s) of evaluation of this end point: The above mentioned parameters is estimated at various timepoints during a 24 hour period INCLUSION CRITERIA: Children with craniosynostosis scheduled for surgery at Department of Neurosurgery, Aarhus University hospital Are the trial subjects under 18? yes Number of subjects for this age range: 30 F.1.2 Adults (18‐64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range