Tranexamic Acids effect on bleeding ,need for blood transfusion and clotting of blood during kraniofacial surgery in children.

Phase 1

Conditions: Bleeding during paediatric Craniosynostosis surgery
MedDRA version: 18.0Level: PTClassification code 10049889Term: CraniosynostosisSystem Organ Class: 10010331 - Congenital, familial and genetic disorders
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2015-000545-22-DK

Lead Sponsor: Aarhus University hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 30

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

Exclusion Criteria

Patients for whom tranexamic acid is thought to be contraindicated.
Patients in another drug trial.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: Bloodloss is estimated at the end of operation and after 24 hours;Main Objective: To assess whether tranexamic acid can reduce peri - and post operative bleeding in children undergoing surgery for craniosynostosis. ;Secondary Objective: To study the effect of tranexamic acid on coagulation and clot stability in children undergoing surgery for craniosynostosis;Primary end point(s): Amount of blood lost during surgery<br>Amount of blood lost in the postoperative period (until 24 hours postoperative)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Hemoglobin<br>Amount of fluids administered during surgery and until 24 hours postoperative<br>Duration of surgery<br>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