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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-000545-22-DK

Enrollment

Registered

2015-04-16

Start date

2015-08-05

Completion date

Unknown

Last updated

2018-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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 de

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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 Amount of blood lost in the postoperative period (until 24 hours postoperative)	—

Measure

Time frame

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 Amount of blood lost in the postoperative period (until 24 hours postoperative)

—

Secondary

Measure	Time frame
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	—

Countries

Denmark

Contacts

Public ContactNeuroanesthesia trial info/CFE

Aarhus University hospital

Christian.Fenger-eriksen@viborg.rm.dk4578463333

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026